FDA WARNING_LETTER - Merck & Co Inc.

The FDA's Center for Veterinary Medicine (CVM) issued a Warning Letter to Merck & Co., Inc., regarding its subsidiary Intervet Inc.'s failure to submit required Three-Day NADA/ANADA Field Alert Reports (FARs) for Vetsulin (porcine insulin zinc suspension), NADA 141-236. Intervet Inc. violated 21 CFR 514.80(b)(1) by not reporting product and manufacturing defects that could lead to serious adverse drug events within three working days of discovery.

Specifically, Intervet Inc.'s analytical testing revealed that several Vetsulin batches (b)(4) and (b)(4) did not meet stability specifications for non-extractable insulin before their expiration dates. Such out-of-specification results for insulin products can lead to serious adverse drug events and are subject to FAR requirements. Despite being aware of these out-of-specification results, Intervet Inc. failed to submit the required FARs. This failure constitutes a prohibited act under section 301(e) of the Act, 21 USC 331(e).

Merck & Co., Inc. is responsible for investigating and correcting these violations and preventing recurrence. Failure to promptly correct these issues may result in legal action, including seizure and injunction, and may impact eligibility for federal contracts. A written response detailing corrective actions, including documentation and a timeline for completion, is required within