FDA 483 - Identipak Inc - December 18, 2025

Identipak Inc, a manufacturer in McAllen, TX, was inspected by the FDA, resulting in three observations related to inadequate quality system and facilities and equipment controls. The firm failed to establish written procedures for annual product reviews, maintain equipment cleaning records, and ensure adequate cleaning and maintenance procedures and validation for non-dedicated equipment used in repackaging OTC drugs. These issues indicate deficiencies in maintaining current Good Manufacturing Practices.