Henan Kangdi Medical Devices Co. Ltd – FDA Warning Letter, Mar 7, 2019

The FDA issued a Warning Letter to Henan Kangdi Medical Devices Co. Ltd. following a March 4-7, 2019, inspection, citing significant CGMP violations for finished pharmaceuticals, rendering their drug products adulterated. The firm manufactures "Capsicum Plaster HOT" and "1st Medx-Patch With 4% Lidocaine," which are also deemed unapproved new drugs.

Key violations include: 1. **Failure to test finished drug products:** The firm did not test each batch for identity and strength of active ingredients before release (21 CFR 211.165(a)). The response was inadequate, lacking details on third-party testing, methods, and retrospective testing of distributed batches. 2. **Failure to test components:** The firm did not test incoming APIs and raw materials for identity, purity, strength, or validate supplier analyses (21 CFR 211.84(d)(1) and (2)). This was a repeat observation from a 2016 inspection. The response was inadequate, not committing to cease manufacturing or addressing risk assessment for distributed products. 3. **Lack of stability testing:** The firm failed to establish an adequate stability program to support product expiration dates (21 CFR 211.137(a)). The response lacked stability protocols, quality attributes, acceptance criteria, and real-time testing assurance.

The FDA noted inadequate quality