PT. MegaSurya Mas – FDA Warning Letter, Nov 15, 2019

The FDA issued a Warning Letter to PT. MegaSurya Mas following an inspection from November 11-15, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their drug product adulterated.

Key violations include: 1. **Inadequate Testing and Method Validation (21 CFR 211.165(a) and (e)):** The firm released OTC drug product (b)(4) to the U.S. without adequate final product testing, with assay results recorded before testing was performed. Analytical methods for active ingredient testing were not validated or verified. 2. **Failure to Test Components (21 CFR 211.84(d)(1) and (2)):** The firm failed to test incoming active pharmaceutical ingredient (API) (b)(4) for identity, purity, and strength, relying solely on supplier COAs without establishing their reliability or performing identity tests. 3. **Failure to Follow Written Procedures for Production and Process Control (21 CFR 211.100(b)):** The firm failed to execute process validation for their drug product, validate their (b)(4) system, and validate their cleaning program. 4. **Inadequate Quality Control Unit (21 CFR 211.22):** The Quality Unit failed to establish procedures for its roles and responsibilities, and its oversight was inadequate, including failures