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 |
|---|---|---|---|---|---|---|---|
| Empower Clinic Services, LLC dba Empower Pharmacy | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | … prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A. … to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use … | ||||
| Specialty Health Products CO, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
… compliance to ISO 10993: Biological Evaluation of Medical Devices. Your QA/RA Manager stated that no such … indicate that the tubing is rated, tested, or approved for medical oxygen delivery applications. Your firm’s risk … system. Your firm has not explained how the body of one procedure was saved under the title of another and has … | ||||
| Lion Street Medical, d/b/a Pensar Medical LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | … Lion Street Medical, d/b/a Pensar Medical LLC … WARNING LETTER CMS #733015 August 21, 2026 Dear … are not limited to, the following: 1. Failure to document one or more processes for risk management in product … | ||||
| Stephen J. Fallon, Ph.D. | Center for Biologics Evaluation and Research (CBER) | Bioresearch Monitoring Program/Institutional Review Board (IRB) |
… dates on the ICFs for these study subjects. Additionally, one study subject's ICF lacked documentation of the date of … signed ICF, nor did he ask if they would like to receive one. Due to these failures, we cannot verify that proper … Control Act Certification, and Export Certificate for Medical Devices from the shipment of the investigational … | ||||
| Fresenius Medical Care AG & Co. KGaA | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | … Fresenius Medical Care AG & Co. KGaA … Warning Letter 320-26-119 August … facility, Fresenius USA Manufacturing, Inc. dba Fresenius Medical Care North America Ogden Plant, FEI 1713747, at 475 … our inspection, you state that you reexamined part of one batch and “found presence of perforations in the primary … | ||||
| R3 Medical Companies | Center for Biologics Evaluation and Research (CBER) | Unapproved New Drugs/Unlicensed Biological Product Violations | … R3 Medical Companies … WARNING LETTER August 14, 2026 CBER … • “One of the major effects is the reduction of inflammation. … to be present in the body and is a known precursor to many medical conditions including organ failure, arthritis, … stem cells and cytokines as well. These facilitate one's body to amp up the repair and regeneration activities … | ||||
| Nipro Renal Solutions USA, Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | … provide a timeframe for completion. 8. Failure to document one or more processes for risk management in product … with exceptions not relevant here, that the label of every medical device bears a unique device identifier (UDI) that … … Center for Devices and Radiological Health … CGMP/QSR/Medical Devices/Adulterated … UDI … 1000142899 … Medical … | ||||
| Koven Technologies, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | … usability, safety and regulatory requirements for the medical device and its intended use, as required by ISO … ID: 98556. The recall is on-going. 2. Failure to document one or more processes for risk management in product … corrective actions are in progress. We acknowledge that one of your corrective actions is that your firm amended the … | ||||
| Linemaster Switch Corporation | Center for Devices and Radiological Health | CGMP/QSR/Drug/Medical Devices/Adulterated | … that your firm manufactures foot pedal accessories for medical devices, including Class II foot pedal controls used with Class IV medical lasers. Under section 201(h) of the Federal Food, … actions that may be required. 2. Failure to document one or more processes for risk management in product … | ||||
| Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. | Center for Drug Evaluation and Research (CDER) | In Vivo Bioavailability-Bioequivalence Studies – Clinical | … [emphasis added] that involves a test article and one or more human subjects and that either is subject to … a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an … except for the use of a marketed drug in the course of medical practice. … Center for Drug Evaluation and Research … |