FDA WARNING_LETTER - PROSANA DISTRIBUCIONES SA DE CV - March 09, 2017

The FDA inspected Prosana Distribuciones S.A. de C.V. in Mexico City from March 6-9, 2017, revealing significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug product adulterated. The inspection also determined their Bicaruvas Antacid Effervescent Powder to be an unapproved new drug and misbranded. CGMP violations included failure to perform final product release testing before distribution (21 CFR 211.165(a)), failure to verify component identity and establish supplier reliability (21 CFR 211.84(d)(1) and (2)), failure to maintain complete batch production records with accurate yield statements (21 CFR 211.188(b)(7)), and failure to establish adequate written procedures for process control and validation (21 CFR 211.100(a)). The firm's March 29, 2017, response was deemed inadequate. Bicaruvas was cited as an unapproved new drug because its claims establish intended use as an antacid, but its formulation (citric acid concentration) does not comply with the OTC Antacid Monograph (21 CFR Part 331), and it lacks evidence of being generally recognized as safe and effective. It was also misbranded (21 U.S.C. 352(c)) due to incomplete bilingual labeling and missing lot/control numbers and expiration dating (21 CFR 201.18, 21 CFR 211.137). The FDA recommended engaging a CGMP consultant. As a result, the firm was placed on Import Alert 66-40, and FDA may withhold new application approvals or refuse product admission into the U.S. A written response detailing corrective actions is required within 15 working days.