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FDAnews Drug Daily Bulletin
July 25, 2012 | Vol. 9 No. 145
Mexican OTC Drugmaker Warned for Missing Test Records, GMP Documents
Compania Internacional de Comercio (CIC), a Mexican maker of OTC topical ointments and gels, has been handed an FDA warning letter for straying from the agency’s good manufacturing practice (GMP) regulations, including failing to document analytical tests and GMP procedures. The OTC drugmaker, also known as Laboratorios KSK, has been placed on import alert and told its future U.S. applications may be held up until all corrections at its Mexico City plant are made.
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