FDA WARNING_LETTER - Jiangsu NHWA Pharmaceutical Co., Ltd. - April 05, 2019

The FDA inspected Jiangsu NHWA Pharmaceutical Co., Ltd. (Jiawang site) from April 1-5, 2019, identifying significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated. Their drug products, specifically (b)(4), are also adulterated for failing to conform to compendial standards.

Key violations include: 1. **Failure to ensure scientifically sound sampling plans and test procedures:** The company used 2015 Chinese Pharmacopeia methods for stability protocols of USP-listed API, which were not demonstrated to be equivalent or superior to current USP 42 compendial methods. Differences in specifications and test methods were found, and required USP quality attribute tests were omitted. Forced degradation studies for USP-grade (b)(4) were also not validated. This also constitutes adulteration under 501(b) of the FD&C Act. 2. **Failure to adequately investigate and document out-of-specification (OOS) results:** (b)(4) batches of (b)(4) API failed release testing due to foreign particles, and investigations (OOS-201607109, OOS-201608130) failed to identify the root cause. Additionally, (b)(4) of (b)(4) API (b)(4) were returned due to foreign