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Effective URL: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities...
Submission: On August 18 via manual from AU — Scanned from DE
Effective URL: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities...
Submission: On August 18 via manual from AU — Scanned from DE
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Text Content
* Skip to main content * Skip to FDA Search * Skip to in this section menu * Skip to footer links An official website of the United States government Here’s how you know The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. U.S. FOOD AND DRUG ADMINISTRATION * Search * Menu Search FDA Submit search FEATURED * Contact FDA * FDA Guidance Documents * Recalls, Market Withdrawals and Safety Alerts * Press Announcements * Warning Letters * Advisory Committees * En Español PRODUCTS * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood, and Biologics * Animal and Veterinary * Cosmetics * Tobacco Products TOPICS * About FDA * Combination Products * Regulatory Information * Safety * Emergency Preparedness * International Programs * News and Events * Training and Continuing Education * Inspections and Compliance * Science and Research INFORMATION FOR * Consumers * Patients * Industry * Health Professionals * Federal, State and Local Officials In this section: Compliance Actions and Activities * Warning Letters * About Warning and Close-Out Letters * Tobacco Retailer Warning Letters 1. Home 2. Inspections, Compliance, Enforcement, and Criminal Investigations 3. Compliance Actions and Activities 4. Warning Letters 1. Compliance Actions and Activities WARNING LETTERS Subscribe to Email Updates * Share * Tweet * Linkedin * Email * Print Learn about the types of warning letters on FDA's website. * Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter. * To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request. Search FILTER BY Issuing Office Letter Issue Date - Any -Last 7 DaysLast 30 DaysLast 60 DaysLast 90 Days Letters with Response or Closeout - Any - Response Letters Closeout Letters Response and Closeout Letters Posted Date - Any -Last 7 DaysLast 30 DaysLast 60 DaysLast 90 Days Year - Any - 20222021202020192018 Hide lower priority columns Showing 1 to 10 of 3,197 entries Show 102550All entries Export Excel Posted DateLetter Issue DateCompany NameIssuing OfficeSubjectResponse LetterCloseout LetterExcerpt 08/17/2022 08/17/2022 Meddle Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 08/16/2022 08/16/2022 Vape NV LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 08/16/2022 08/08/2022 Oregon’s Wild Harvest, Inc. Division of Human and Animal Food Operations West VI CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated 08/16/2022 03/30/2022 Verde Cosmetic Labs LLC Division of Pharmaceutical Quality Operations IV CGMP/Finished Pharmaceuticals/Adulterated 08/16/2022 08/10/2022 Cangene BioPharma, LLC dba Emergent BioSolutions Division of Pharmaceutical Quality Operations I CGMP/Finished Pharmaceuticals/Adulterated 08/16/2022 07/29/2022 Deggeh Foods, Inc. Office of Human and Animal Food Operations East – Division 1 Unapproved New Drugs/Misbranded 08/16/2022 07/28/2022 EH Maldonado and Company Division of Southwest Imports Foreign Supplier Verification Program (FSVP) 08/16/2022 07/21/2022 Cantoro Food Market Division of Northern Border Imports Foreign Supplier Verification Program (FSVP) 08/16/2022 08/12/2022 Rev Products LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 08/16/2022 08/12/2022 Vapewell Supply LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded Loading... Showing 1 to 10 of 3,197 entries * First * Previous * 1 * 2 * 3 * 4 * 5 * … * 320 * Next * Last Download XLSX Download XLSX CONTENT CURRENT AS OF: 08/17/2022 * * Warning Letters * About Warning and Close-Out Letters * Tobacco Retailer Warning Letters SUBSCRIBE Get regular FDA email updates delivered on this topic to your inbox. Enter your email address to subscribe: FOOTER LINKS * FDA Archive * About FDA * Accessibility * Visitor Information * Website Policies / Privacy * No FEAR Act * Vulnerability Disclosure Policy * FOIA * HHS.gov * USA.gov Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Back to Top