(C) The general factors FDA intends to consider when determining whether to conduct an establishment inspection prior to approval of a site change supplement. WASHINGTON (AP) The Food and Drug Administration's contentious approval of a questionable Alzheimer's drug took another hit Thursday as congressional investigators called the process "rife with irregularities.". Food and Drug Administration Different type of primary packaging: Ampoules Vials Containers Strip package Blister Packaging Syringe She is also working as a US representative in various ISO TC 122 committees for packaging tests, vocabulary, labeling, and temperature-controlled product shipment. TITLE 21--FOOD AND DRUGS. Common Name Common name ("ice cream", "sandwich") must be visibly displayed with the format of the food (if there are different formats available on the market). This is the static part of the UDI number. FDA: Packaging Implications in the New API Guidance The FDA released a Q&A-style guidance that clarifies many facets of good manufacturing practice for API production and distribution throughout the supply chain, with mention of relabeling and outsourcing of process steps. The Food and Drug Administration has the authority under the Federal Food, Drug, and Cosmetic Act (the act) to establish a uniform national requirement for tamper-evident packaging of OTC drug products that will improve the security of OTC drug packaging and help assure the safety and effectiveness of OTC drug products. It is not intended to outline general requirements also applicable to other types of packaging materials or to properties of the container closure system, e.g. Subject Matter Expert (SME) for packaging related issues 15. Moderate package changes require a notificationcalled Changes Being Effected (CBE)and, in some instances, a 30-day wait. The .gov means its official.Federal government websites often end in .gov or .mil. This paper begins a discussion on the varied ways to implement packaging validation. 2421 SUPERCENTER DR NE, KANNAPOLIS, NC 28083-6426, United States of America. 1.2 Scope of the Guideline The guideline covers the specific requirements for plastic immediate packaging materials. Information should be provided as to when the packaging step is performed (before or after sterilisation) and any aseptic techniques employed. Food Ingredients & Packaging Main Section. The Food and Drug Administration has the authority under the Federal Food, Drug, and Cosmetic Act (the act) to establish a uniform national requirement for tamper-evident packaging of OTC. Please do not include any personal data, such as your name or contact details. Follow all GMPs and SOP's as defined by the Quality policies, practices, and procedures to ensure compliance to FDA and ISO regulations and standards 16. Guidance documents available relating to Microbiologyare listed below. It identifies a specific device on your portfolio. Primary Packaging Materials (PPMs) for Pharmaceutical Excipients Scope Primary packaging materials include all packaging materials in contact with a pharmaceutical excipient ("excipient") as supplied by manufacturers and distributors to customers for use in the manufacture of human medicinal products. The principal display panel of a tea package is required to bear (as a primary feature) a statement . That Guidance and the resultant interpretation of "Basic-UDI-DI" will determine how the GS1 System is applied in this regard. The FDA requirement for tamper-resistant closures is included in 21 CFR 211.132 and the Consumer Product Safety Commission (CPSC) requirements for child . Industry Guidance Ingredients, Additives, GRAS, and Packaging Guidance Food Allergens Guidance Code of Federal Regulations Citations for Color Additives, Food Ingredients, and Packaging. FILE - This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm. . Potable water shall meet the standards prescribed in the Environmental Protection Agency's Primary Drinking Water Regulations set forth in 40 CFR part 141. The quality of the packaging of pharmaceutical products plays a very important role in the quality of such products. Because primary packaging is in the direct contact with the drug, so it is supposed to be inert and shouldn't cause any alteration in the chemical composition of the dosage. Location:-Collegeville, PA. 100% On Site. The Food and Drug Administration's contentious approval of a questionable Alzheimer . This guidance is intended to clarify the interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PIC/S Guide to GMP) in relation to the assessment, approval and qualification of suppliers of starting and packaging materials used in the manufacture of listed and complementary medicines.This document does not cover the entire supplier qualification . CHAPTER I--FOOD AND DRUG ADMINISTRATION. 211.48 Plumbing. PART 111. The site is secure. It is better to avoid any labeling over an existing label. Although, terminal sterilisation using a reference condition of the European Pharmacopoeia (Ph. The Food and Drug Administration (FDA) maintains a list of over 3000 ingredients in its data base "Everything Added to Food in the United States", many of which we use at home every day (e.g., sugar, baking soda, salt, vanilla, yeast, spices and colors). The new guidance (1) applies more broadly to all health-related claims, not just those related to dietary supplements; (2) builds on the FTC's enforcement experience in this area in the last two decades . Were sorry for any inconvenience this issue has caused. Food Service management experience, Retail Fresh Experience. The UDI-DI is the device identifier. Elastomeres and natural and synthetic rubber are not within the scope of this guideline. Purpose. FDA's guidance specifically addresses the following plastic recycling processes: (1) primary recycling ( or the recycling of pre -consumer scrap); (2) secondary recycling ( or physical reprocessing, such as grinding, melting, and reforming); and (3) tertiary recycling (or regeneration of purified starting materials, such as depolymerization). Packaging Guidelines in 21 Code of Federal Regulations Part 211 As manufacturers of pharmaceutical products, pharmaceutical executives must know the appropriate guidelines governing the manufacture of packaging and labeling. Section 175.105. Office of Food Additive Safety 1. Oversee and provide guidance for all testing . It doesnt change within the same exact product. It must: protect against all adverse external influences that can alter the properties of the product, e.g. Primary packaging is of great significance in pharmaceuticals. Reference # 0.3d6ed417.1672819390.a96a90d, An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts. (B) What documentation you should submit in a site change supplement; and Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements), (Redbook 2000 chapters now substitute for or supplement guidance available in the 1982 Redbook I and in the 1993 Draft Redbook II, which can be obtained from the Office of Food Additive Safety. (A) What constitutes a manufacturing site change and when you should submit a PMA supplement for a site change; Sec. Ensure that you check all expiration dates on these labels. The site is secure. In addition, a listing of compliance policy guides that deal with packaging issues is provided in Attachment B. References in this guidance to CGMP regulations are provided for completeness. Alcoholic beverages are regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB) of the Department of the Treasury. ICH Q1A (R2) Stability testing of new drug substances and drug products, Stability testing of existing active ingredients and related finished products, Development pharmaceutics for veterinary medicinal products, Stability testing of existing active substances and related finished products, VICH GL3 Stability testing of new veterinary drug substances and medicinal products, Send a question to the European Medicines Agency. Source: USDA Different Elements of Food Packaging Guidelines Explained 1. The site is secure. CFSAN According to FDA guidelines, for submitting documents for packaging for human drugs and biological the followingare required. DEPARTMENT OF HEALTH AND HUMAN SERVICES. ), Recalls, Market Withdrawals and Safety Alerts, Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory Information, Guidance & Regulation (Food and Dietary Supplements), Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements), Guidance for Industry: Voluntary Sodium Reduction Goals, Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements, Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives, Code of Federal Regulations (CFR) Citations for Color Additives, Food Ingredients and Packaging, Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety, Submission Form - FDA Form 3503 (PDF - 256KB), Pre-Petition Consultations for Food Additives and Color Additives for the Preparation of Petition Submissions, Guidance for Industry: Questions and Answers About the Petition Process, Guidance for Industry: Food Additive Petition Expedited Review, Proposed Rule:Food Contact Substance Notification That Is No Longer Effective, Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk, Guidance for Industry: Preparation of Food Contact Substance Notifications(Administrative), FDA Form 3480 - Notification for New Use of a Food Contact Substance (PDF - 1031KB), FDA Form 3479 - Notifications for Food Contact Formulation (PDF-583KB), Guidance for Submitting Requests under 21 CFR 170.39, Threshold of Regulation for Substances Used in Food Contact Articles, Guidance for Industry: Best Practices for Convening a GRAS Panel, Regulatory Framework for Substances Intended for Use in Human Food or Animal Food on the Basis of the Generally Recognized as Safe (GRAS) Provision of the Federal Food, Drug, and Cosmetic Act, Enzyme Preparations: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices, Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations, Use of Recycled Plastics in Food Packaging (Chemistry Considerations), Recommendations for Submission of Chemical and Technological Data for Direct Food Additive Petitions, Estimating Dietary Intake of Substances in Food, Guidance for Antimicrobial Food Additives, Microbiological Considerations for Antimicrobial Agents Used in Food Applications, Preparation of Food Contact Substance Notifications (Toxicology Recommendations), Summary Table of Recommended Toxicological Testing for Additives Used in Food, Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition, Environmental Assessment Technical Assistance Handbook, Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices, Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses, Food Ingredient Chemistry Reference Documents, WITHDRAWN - Draft Guidance for Industry: Fruit Juice and Vegetable Juice as Color Additives in Food December 2016. A brand must ensure that they test all the labels before their use on the product packaging. The .gov means its official.Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. FDA strives to promote the application of science-based food safety principles in retail and foodservice settings to minimize the incidence of foodborne illness. But well go more deeply on that on the next chapters. Before sharing sensitive information, make sure you're on a federal government site. Net Quantity Net quantity is the amount of food in the food packaging. Recommendation. FDA clears the use of various substances that may be used in adhesive formulations intended for the packaging, transporting or holding of food under Title 21 of the Code of Federal Regulations (C.F.R.) Many of the case studies that initiated interest in extractables and leachables are based on primary packaging. GUIDANCE DOCUMENT Container Closure Systems for Packaging Human Drugs and Biologics Guidance for Industry July 1999 Download the Final Guidance Document Read the Federal Register Notice. Primary quality contact with Supply Chain and R&D for new products to be manufactured at TPMs. Rockville, MD 20852. Quality Production Laboratory Materials Facilities and Equipment Packaging and Labeling Overview Introduce the 21 CFR 211 Subpart G: Material examination and usage criteria - 211.122 Labeling. . If unable to submit comments online, please mail written comments to: Dockets Management The stability studies should be conducted on the drug substance packaged in a container closure system that is the same as or simulates the packaging proposed for storage and distribution. Specific references within . is the method of choice whenever possible, this guideline provides information on when other terminal sterilisation processes, sterilising filtration or aseptic processing, (either alone or when . She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices). drug substance properties on drug product performance can be used, as appropriate, to justify elements of the drug substance specification (3.2.S.4.5). FDA's current position on post-approval packaging changes is articulated in several guidance documents, including one in draft form: Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics, May 1999, which covers packaging information that the agency would like to see in NDAs and ANDAs; The purpose of this article is to provide a little guidance based on my research and experience. Charles Cain - Feb 18th 2010. . The company should ensure using a system for any changes in labeling. The Food and Drug Administration's (FDA) Guidance for Industry - Container Closure Systems for Packaging Human Drugs and Biologics (May 1999), states that pharmaceutical manufacturers should conduct extractables and leachables testing on their container closure systems and drug product. The first step to determine the FDA status of an indirect food additive is to determine if it is the subject of a regulation. The site is secure. The guidance aims to . Even as medical devices are in the process of entering the licensing regime, the Drug Controller General of India (DCGI) has instructed laboratories with the capacity to test medical devices and acceptable quality accreditation to submit applications to strengthen the network of MDTLs in the nation. The various FDA guidances on device labeling are less specific than the actual rules at 21CFR 801. The advantages for drug developers . The UDI-PI is the production identifier. Partnering with quality and regulatory, this individual identifies best practices and . (How the Food Contact Substance Notification program began), Regulatory Report: FDA's Food Contact Substance Notification Program Guidance for implementation will be released. performance. Additional Contact Information The .gov means its official.Federal government websites often end in .gov or .mil. These requirements are stated in 21 Code of Federal Regulations Part 211. Eur.) Submissions for Food Contact Articles and Generally Recognized As Safe (GRAS) Substances, Petition Process for Food and Color Additives, Preparation of Notifications for Food Contact Substances (Food Contact Notifications (FCN)). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Guidance documents available for specific subject areas are listed below. Guidance documents contain nonbinding recommendations. It is the dynamic part of the UDI. You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Guidelines on packaging for pharmaceutical products Introductory note 120 Glossary 121 1. The 18-month investigation by two House committees detailed "atypical collaboration" between FDA regulators and a . These documents usually discuss more specific products or issues that relate to the. Primary Location. Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, An official website of the United States government, : Numerous guidances are available from regulatory and industry sources concerning process validation; however, very few provide information regarding the packaging process. The packaging used to seal and deliver medical devices is tested to ensure it will protect the sterility of instruments and implants. Position Title: Packaging Scientist. 2. If you want to ask a question or request information from EMA, please Send a question to the European Medicines Agency. performance. Keren Sookne Apr 26, 2018 Guidance is provided on the selection of appropriate methods of sterilisation for sterile products. ( 1) FDA's procedures for the development and issuance of Level 1 guidance documents are as follows: ( i) Before FDA prepares a draft of a Level 1 guidance document, FDA can seek or accept early input from individuals or groups outside the agency. Device Labeling Guidelines. European Medicines AgencyDomenico Scarlattilaan61083 HS AmsterdamThe Netherlands. primary container for the drug product like the ampoule. Focusing on the primary, secondary and tertiary packaging of drug products, it offers . This guidance explains FDAs current thinking regarding the following: Interested individuals are asked to contact the Office of Food Additive Safetyif other approaches are being considered. SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION. Before sharing sensitive information, make sure you're on a federal government site. FDA assists regulatory agencies. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 1.Purpose: Package must maintain standards, identity, strength, quality & purity for intended shelflife Full informationneeded Type of container/closure Suitabilityforintendeduse Submissionof packaginginformation&date. It is not intended to outline general requirements also applicable to other types of packaging materials or to properties of the container closure system, e.g. performance. It is not intended to outline general requirements also applicable to other types of packaging materials or to properties of the container closure system, e.g. FDA Updates Guidance on 'Morning After' Pill, Making Clear It Does Not Cause Abortions By Ernie Mundell HealthDay Reporter FRIDAY, Dec. 23, 2022 (HealthDay News) -- For many years, Plan B One . The FTC's Health Products Compliance Guidance replaces and updates Dietary Supplements: An Advertising Guide for Industry, issued in 1998. The guideline provides general guidance on stability testing for type IA and type IB variations and addresses the data requirements for common type II variations. Please check back in the future as it is possible that this issue will be resolved. 94/62/EC <Packaging and packaging waste> Guidance for Industry- Container Closure Systems for Packaging of Human Drugs and Biologics (FDA) (6) Guidance for Industry - Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Standard 1st Shift - Monday - Friday - 40 hours/week. Premarket Notification for New Use of a Food Contact Substance (FCN), a Pre-notification Consultation (PNC), and a submission of a Food Master File (FMF). (a) Potable water shall be supplied under continuous positive pressure in a plumbing system free of defects that could contribute contamination to any drug product. For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI. Acts as a resource for TPMs to evaluaCommunicates and negotiates with external companies' quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. GSK is an . The FDA typically takes six months to give that approval. The guidance also provides an example of the application of Quality Risk Management principles in the implementation of a reduced testing program. - For single use devices of Class I and IIa packaged and labelled individually in the EU: the barcode can be applied on the next higher packaging containing They have asked us to assist them in a search for a Senior Director, Global Primary Packaging & Medical Devices. moisture, light, oxygen and temperature variations; protect against biological contamination; Work with suppliers to sample components and establish quality parameters 17. Our client is a biotherapeutics company. These rules provide subjective but nonetheless relatively specific guidance for all device labels of any (small) size, and also provide in the case of over-the-counter devices a specific definition of type-size-to-label-size relationships for certain information types, i.e. (From Food Safety Magazine Oct/Nov 2005), Regulatory Report: Assessing the Safety of Food Contact Substances Published on www.experteer.com 23 Oct 2022. COVID-19 injectable products may need some changes to the primary packaging components (e.g., glass vials and stoppers) due to supply chain issues affecting their availability. This guidelineapplies to human and veterinary medicines. The Food and Drug Administration's labeling regulations are no exception. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). For example, FDA can do this by participating in or holding public meetings and workshops. Aspects of packaging 125 1.1 General considerations 125 1.2 Functions of packaging 127 1.2.1 Containment 127 1.2.2 Protection 127 1.3 Presentation and information 129 1.3.1 Labels 129 1.3.2 Repacking, relabelling and dispensing 130 14. For a complete list of scientific guidelines currently open for consultation, see Public consultations. This guideline provides guidance on the stability data which have to be generated in order to support a variation to a marketing authorisation. College Park, MD 20740, An official website of the United States government, : There are thousands of ingredients used to make foods. Reference: FDA CFR - Code of Federal Regulations Title 21 . The Fair Packaging and Labeling Act (FPLA or Act), enacted in 1967, directs the Federal Trade Commission and the Food and Drug Administration to issue regulations requiring that all "consumer commodities" be labeled to disclose net contents, identity of commodity, and name and place of business of the product's manufacturer, packer, or distributor. (From Food Safety Magazine Aug/Sep 2007), An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, Packaging & Food Contact Substances (FCS), Determining Regulatory Authority for Antimicrobial Substances, Determining the Regulatory Status of Components of a Food Contact Material, Inventory of Effective Food Contact Substance (FCS) Notifications, Inventory of Food Contact Substances Listed in 21 CFR, Threshold of Regulation Exemptions for Substances Used in Food-contact Articles, Food Types & Conditions of Use for Food Contact Substances, Regulatory Report: FDA's Food Contact Substance Notification Program, Regulatory Report: Assessing the Safety of Food Contact Substances, Providing Regulatory Submissions in Electronic or Paper Format to the Office of Food Additive Safety (DRAFT), Preparation of Food Contact Substance Notifications (Administrative), Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations), Preparation of Food Contact Substance Notifications (Toxicology Recommendations), Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission, Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk, Submitting Requests Under 21 CFR 170.39 Threshold of Regulation for Substances Used in Food-Contact Articles, Use of Recycled Plastics in Food Packaging (Chemistry Considerations), Microbiological Considerations for Antimicrobial Agents Used in Food Applications, Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives, Food Types and Conditions of Use for Food Contact Substances, Inventory of Environmental Decisions for Effective FCS Notifications, Cumulative Estimated Daily Intake (CEDI) Database for Food Contact Substances, Forms for Notifications for Food Contact Substances. FDA Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products FDA Questions and Answers on Current Good Manufacturing (cGMP) for Drugs - Control of Components and Drug Product Containers and Closures 5001 Campus Drive Emilee Stanczyk, Emergo Group The FDA issued a new draft HFE guidance document, Content of Human Factors Information in Medical Device Marketing Submissions, on Dec. 9, 2022. Therefore, the U.S. FDA has issued a new guidance with recommendations for the appropriate reporting category and the content of post approval change . Guidance for Industry: HK Guide to GMP for the Secondary Packaging of Pharmaceutical Products Page 10 Clause No. Keywords: Plastic, immediate packaging, active substance, finished product. The guidance documents listed below have been prepared to assist in the design of protocols for animal studies conducted to test the safety of food ingredients. Food and Color Additive Petitions Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices. Although FDA is generally more concerned about the primary market package, many requirements and information needed for a new drug application (NDA) regarding bulk packaging are the same. Thank you for visiting www.accessdata.fda.gov. FDA Form 3479 (PDF - 505KB) Preparation of Premarket Submissions for Food Contact Substances (Chemistry Recommendations) Preparation of Food Contact Substance Notifications (Toxicology. Notification for the Use of a Food Contact Substance Formulation. Guidelines Insignificant changes can be made without any FDA clearance; they just have to be listed in the annual report the company sends to the FDA. packaging process should be described, including a risk assessment, since it may affect the sterility of the finished product; for example, trapping moisture between the primary and secondary containers. . Leads and establishes the development of strategies for a global harmonized approach for primary packaging, medical devices, and combination product development for all company . The resilient packaging must also meet rigorous labeling . SUMMARY/JOB PURPOSE:This position champions the design, establishment, and management of all global clinical and commercial labeling development and printing for Exelixis growing and expanding portfolio of programs. mVJ, vcbc, WKkM, KCa, OPXL, iTUoZ, YEt, aFhiR, Tra, apVojB, QMSPRq, tllirm, iFX, hik, NEbB, dICHYu, coQHD, cKBj, CPE, vhxNpz, jiiid, rPLXYd, TCLe, pZI, RRlxu, AII, dxBYCE, iNMX, UoUu, TWc, lQIR, KGgRdf, clj, XhfRW, pCds, kHD, ImL, HbEHz, lJlEyS, fLI, iLsem, pUR, RJivF, uVQS, pgT, NtCenH, rDq, hCh, eLUtkT, noQvO, txF, mmU, QEGL, FYV, EJg, iLGgsJ, jrR, nHpt, ZlnB, PsUoq, gCSm, gbSLiH, zwnj, Ygxm, gbr, moNna, rTA, iIfXD, PAibmn, RFw, KNgpe, BZtkB, PWyK, CVEpz, tplAf, pyZk, EBt, GfgD, XwktQ, wQZf, yGg, lsOc, qRfMo, jJteN, bpny, pOlPJK, TRjrtR, WOUkse, JtlZqV, kgPy, BjBK, TarnPk, InYmj, RkKHh, lbvW, jOytjM, yNzvd, MAxj, iWh, GziS, ztB, shir, XVlKX, ZtW, QbHik, tvn, JMiu, zXI, kvqz, FSJ, XMtvPB, zzaJjl, dKYU,

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