FDA WARNING_LETTER - Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. - December 08, 2023

The FDA issued a Warning Letter to Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. following an inspection from December 4-8, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Violations include: 1. **Failure to establish adequate laboratory controls (21 CFR 211.160(b))**: * **Drug Products Lacked Appropriate Specifications**: The firm failed to establish appropriate release specifications and analytical testing for critical quality attributes. For example, an OTC drug product with two active ingredients only had a single assay specification and result on its Certificate of Analysis. The company's response was inadequate, lacking specific details, timelines, protocols, or updated test methods. * **Inadequate (b)(4) Testing**: The firm lacked appropriate specifications for (b)(4) used as a component, only testing for total aerobic microbial count and not for objectionable microorganisms. Their procedure also did not specify microbial identification of (b)(4) system sample isolates. The response was inadequate, unclear if USP compendial methods would be followed, and did not indicate testing for objectionable microorganisms beyond *Burkholderia cepacia complex*.

2. **Failure to establish an adequate quality control unit (21 CFR 211.22(a))**: The Quality Unit (QU) did not effectively oversee drug manufacturing operations, specifically failing