Ningbo Poplar Daily-Use – FDA Warning Letter, Feb 13, 2024

The FDA issued a Warning Letter to Ningbo Poplar Daily-Use, a manufacturer of OTC drug products, following a review of records submitted in response to a Section 704(a)(4) request. The letter identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to test finished drug products prior to release (21 CFR 211.165(a)):** The firm did not perform assay or (b)(4) testing on finished (b)(4) drug products. The provided "Drug Facts Label" was insufficient as specifications, and the test method using a hydrometer was unsuitable for the product matrix, violating 21 CFR 211.160(b). The FDA requires an action plan for full chemical and microbiological testing of retain samples for all in-expiry batches distributed to the U.S., with a summary of results and rapid corrective actions if substandard. 2. **Failure to verify the identity of each component (21 CFR 211.84(d)(1)):** The firm did not demonstrate identity testing of incoming components, including (b)(4) for (b)(4) content. Only supplier test reports were provided, lacking scientific evidence of raw material conformity. 3. **Failure to establish an adequate stability testing program (21 CFR 211.16