FDA WARNING_LETTER - Selder S.A. de C.V. - September 23, 2011

An FDA inspection of Selder S.A. de C.V.'s pharmaceutical manufacturing facility in Mexico from September 19-23, 2011, revealed significant Current Good Manufacturing Practice (CGMP) violations and misbranding issues, rendering their drug products adulterated and misbranded. CGMP deficiencies included an inadequate stability testing program (21 CFR § 211.166(a)), lack of written procedures for monitoring and validating manufacturing processes (21 CFR § 211.110(a)), insufficient production and process controls (21 CFR § 211.100(a)) including unvalidated processes, incomplete laboratory control records (21 CFR § 211.194(a)), and failure to validate test methods (21 CFR § 211.165(e)). Misbranding violations under Section 502(f)(2) of the Act stemmed from non-compliance with FDA's organ-specific labeling for acetaminophen-containing OTC products (21 CFR § 201.326) and failure to include required warnings for antihistamine drug products (21 CFR 341.72(c)). The FDA questioned the effectiveness of the firm's quality system and recommended a third-party consultant. Selder S.A. de C.V. must provide a written response within 15 working days detailing corrective actions, including comprehensive reviews of stability data, process validation, analytical records, and method validations. Failure to comply will result in continued refusal of admission for products into the U.S. via Import Alert and potential withholding of new drug application approvals.