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 |
|---|---|---|---|---|---|---|---|
| ZOLL Medical Corporation | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | … Number 5004-0003-RP, Revision YE and as per Procedure, Health Risk Assessment, Document Number 5005-000149-RP, … the pads from the patient and found corrosion at the center of the metal element of the posterior portion of the … Electrodes, Pedi-Padz LG Electrodes, Aspirator and G3/G3 Elite were finalized following Quality Assurance Management … | ||||
| Royal Philips | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated/Misbranded | … manufacture a variety of medical devices, such as the EPIQ Elite Ultrasound system, manufactured at Bothell, Ultrasound … however, this malfunction does not pose a risk to health of patients, users, or bystanders and did not allege a … Deputy Director Office of Product Evaluation and Quality Center for Devices and Radiological Health Cc: Jeffrey M. … | ||||
| Elite Health Center | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet (Telehealth) | … Elite Health Center … WARNING LETTER September 9, 2025 Elite Health Center: This letter is to advise you that the … | ||||
| Bio Wellness 444 LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | … website, biowellness444.com, where your “Silver Bullet elite douche” and “Silver D elite douche” drug products are … for over 2,000 years to relieve the symptoms of various health condition including the effects of viruses and … Drugs and Labeling Compliance Office of Compliance Center for Drug Evaluation and Research Food and Drug … | ||||
| Spectrum Medical Ltd | "OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality" | CGMP/QSR/Medical Devices/Adulterated | … or directly connected to the new Quantum Workstation Elite during transport.” Your pump is cleared with an … for ECLS procedures other than CPB, raise serious public health concerns when used for those procedures, because … Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health for CC: Colleen … | ||||
| Ammonia Sport Inc. | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | … to get their head in the game is becoming synonymous with elite level performance.“ “-Supports Explosive Energy -Sharp … Sincerely, /S/ Tina Smith, M.S. Captain, U.S. Public Health Service Director Office of Unapproved Drugs & Labeling Compliance Office of Compliance Center for Drug Evaluation and Research U.S. Food and Drug … | ||||
| Elite Supplement Center LLC and Elite Training Facility LLC | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug | … Elite Supplement Center LLC and Elite Training Facility LLC … WARNING LETTER July 6, 2022 … excellent lean muscle gains while helping bone and joint health as well as muscle recovery. This makes it a great … |