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 |
|---|---|---|---|---|---|---|---|
| Chemco Corporation | Center for Drug Evaluation and Research (CDER) | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | … Chemco Corporation … Over-the-Counter Drugs … Warning Letter … (FDA) inspected your drug manufacturing facility, Chemco Corporation, FEI 1042599, at 4920 NW 165th St., Miami Lakes, … |