Nan San (HK) Pharmaceutical Factory Ltd. – FDA Warning Letter, Sep 29, 2017

The FDA issued a Warning Letter to Nan San (HK) Pharmaceutical Factory Ltd. following a September 25-29, 2017 inspection, citing significant CGMP violations and misbranded drug products. The firm's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key CGMP violations include: 1. **Failure to test drug products prior to release (21 CFR 211.165(a) and (b))**: The firm did not perform microbial limit tests for all batches of OTC topical liquid analgesics (e.g., Easy-Flex) and relied on a contract laboratory that only tested one of multiple active ingredients. 2. **Lack of written production and process control procedures (21 CFR 211.100(a))**: The firm has not validated manufacturing processes for OTC drug products and lacks an ongoing process control monitoring program. 3. **Failure to test components for identity (21 CFR 211.84(d)(1))**: Incoming active pharmaceutical ingredients and other components were not tested for identity, purity, strength, and quality before use. 4. **Inadequate stability testing program (21 CFR 211.166(a))**: The firm assigned a 3-year expiration date without sufficient stability data.

The firm'