FDA WARNING_LETTER - Taiwan Three Mast Pharmaceutical Co.Ltd. - April 27, 2012

This FDA Warning Letter, dated December 17, 2012, was issued to Taiwan Three Mast Pharmaceutical Co., Ltd. following an inspection from April 23-27, 2012. The inspection revealed significant violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated. Additionally, their "Imbue Pain Relief Patch" was identified as an unapproved new drug.

Key CGMP violations include: 1. **Lack of Finished Product Testing:** Failure to perform appropriate laboratory determination of active ingredient strength (menthol/methyl salicylate) for finished drug products, relying only on TLC for identity. 2. **Inadequate Component Testing:** Failure to test incoming raw materials (menthol and methyl salicylate APIs) for purity, strength, and quality, relying solely on unvalidated supplier Certificates of Analysis (COA). 3. **Unvalidated Manufacturing Processes:** Failure to establish adequate written procedures for production and process controls, with manufacturing processes for several products (e.g., Imbue Pain Relief Patch, Panlax Herbal Patch) remaining unvalidated since 2010. 4. **No Annual Product Reviews:** Failure to conduct annual quality reviews of drug products distributed to the U.S. since 2010. 5. **Insufficient Employee Training:** Failure to provide CGMP training to employees