Haw Par Healthcare Limited – FDA Warning Letter, Oct 29, 2009

On July 20, 2010, the FDA issued a Warning Letter to Haw Par Healthcare Limited following an October 26-29, 2009 inspection of their OTC drug manufacturing facility in Singapore. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), causing their drug products to be adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act. Additionally, TIGER BALM® Pain Relieving PATCH was found to be misbranded under section 502(a) and an unapproved new drug under section 505(a) of the Act.

Key violations include: 1. **Inadequate Specifications and Test Procedures (21 CFR § 211.160(b)):** Lack of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures. Specific issues included inadequate specificity tests for KWAN LOONG OIL® PAIN RELIEVING AROMATIC OIL and Tiger Balm, absence of forced degradation studies, unidentified unknown peaks in stability studies, undocumented instrument and method parameters, failure to assess residual solvents, and inadequate GC assay method validation for methyl salicylate API. 2. **Failure to Investigate Discrepancies (21 CFR § 211.192):** Failure to thoroughly investigate unexplained