Warning Letters
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.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Peak Performance Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Reliance Life Sciences Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Jabil Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Shoolin Pharma Chem LLP | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
| Royal Peptides LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| NuScience Peptides LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Peptide Partners LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| TXP Innovations LLC dba Tex Peptides | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Mesquite Gourmet LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
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| B&P Mutual Corp | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |