Haw Par Healthcare Limited – FDA Warning Letter, Mar 1, 2019

The FDA issued an amended Warning Letter to Haw Par Healthcare Limited following a February 25 to March 1, 2019, inspection of their Singapore drug manufacturing facility. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations, rendering their drug products adulterated. Additionally, "TIGER BALM LINIMENT" was found to be misbranded.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm invalidated out-of-specification (OOS) test results for active pharmaceutical ingredients (API) and drug products without scientific justification, failing to adequately investigate root causes for OOS results and customer complaints regarding lack of drug effect. Their response regarding API mixing homogeneity was deemed insufficient. 2. **Insufficient Laboratory Controls (21 CFR 211.160(b)):** The firm failed to establish scientifically sound stability acceptance criteria from forced degradation studies and did not adequately monitor drug products for impurities or degradation products. Their interim plan for product purity was inadequate. 3. **Incomplete Laboratory Records (21 CFR 211.194(a)):** Computer systems for analytical instrumentation lacked audit trail capabilities, compromising data integrity. The proposed interim plan to protect raw data was insufficient. 4. **Inadequate Equipment Design (21 CFR 211.63):** The purified water system had "dead