FDA WARNING_LETTER - Contract Pharmacal Corporation - April 28, 2010

On April 8-28, 2010, an FDA inspection of Contract Pharmacal Corporation's Hauppauge, NY facility revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering drug products adulterated. The company also manufactures unapproved new prescription drugs, violating sections 505(a) and 502(f)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Production and Process Controls (21 CFR § 211.100(a)):** Lack of written procedures and appropriate process validation for products like Caffeine 100 mg, Acetaminophen 500 mg/Pamabrom 25 mg, Diphenhydramine HCl 25 mg, and Methenamine Mandelate 500 mg tablets. Issues included unchanged blending times despite increased batch sizes, and validation runs outside allowable compression and coating parameters. This is a repeat observation from 2000 and 2006. 2. **Insufficient Investigation of Batch Failures (21 CFR § 211.192):** Failure to thoroughly investigate metal slivers in Chlorpheniramine Maleate 4 mg tablets, wrong capsule color for Diphenhydramine HCl 25 mg capsules, and out-of-specification (OOS) assay results for Hyoscyamine Sulfate 0.125