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 |
|---|---|---|---|---|---|---|---|
| Binh Minh Tofu | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | … filth or whereby it may have been rendered injurious to health. Further, we found significant violations of the … | ||||
| Shoolin Pharma Chem LLP | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | … was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, … become contaminated with filth or rendered injurious to health. This warning letter also summarizes significant … manufacturing operations prior to commercial distribution Calibrate and maintain equipment as appropriate for its … | ||||
| Nipro Renal Solutions USA, Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | … conclude that they are not adequate. Your firm provided Health Hazard Assessments (NRSU-RPT-0028 Rev 02 and … these results and your firm’s response (including the Health Hazard Assessment and Customer Notification … levels higher than specification may cause a risk to health, namely (b)(4) reactions. In your response, please … | ||||
| Linemaster Switch Corporation | Center for Devices and Radiological Health | CGMP/QSR/Drug/Medical Devices/Adulterated | … Evaluation and Quality Center for Devices and Radiological Health Cc: Edward Ursillo, Director of Quality Assurance, … (b)(6), (b)(7)(C) … Center for Devices and Radiological Health … CGMP/QSR/Drug/Medical Devices/Adulterated … … | ||||
| DO&CO Aktiengesellschaft/DO&CO, Inc. | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes | … filth, or whereby they may have been rendered injurious to health. In addition, failure of the owner, operator, or agent … listeriosis, a foodborne illness, which is a major public health concern due to the severity of the disease, its high … | ||||
| Pro Numb Tattoo Numbing Spray, LLC | Center for Drug Evaluation and Research (CDER) | Nonprescription/OTC |
… and Research /S/ Tina Smith Captain, U.S. Public Health Service Director Office of Unapproved Drugs & Labeling … | ||||
| Exactech, Inc. dba Advita Ortho | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
… Evaluation and Quality Center for Devices and Radiological Health CC: Christine Thomas, Chief Quality, Clinical and … … Center for Devices and Radiological Health … CGMP/QSR/Medical Devices/Adulterated … 3008658204 … … | ||||
| Diasol, Inc. | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | … Evaluation and Quality Center for Devices and Radiological Health … Center for Devices and Radiological Health … Investigational Device Exemptions (IDE)/Premarket … | ||||
| Palamur Biosciences Private Limited | Center for Devices and Radiological Health | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | … from quarantine, or before the surgical procedure. The health of the animals was not comprehensively examined and … of associated premarket submissions, which may put public health and safety at risk. Your written responses are … Requisition and Issuance Record” as evidence of the health status of the animals, the form lacks detailed … | ||||
| Harbor Marine Product Inc. | Office of Compliance and Enforcement | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
… whereby they may have been rendered injurious to health. Furthermore, in accordance with 21 CFR 123.6(g), … listeriosis, a foodborne illness which is a major public health concern due to the severity of the disease, its high … fish that are consumed as raw, RTE. In practice, you calibrate all thermometers in-house (b)(4) by comparing the … |