FDA 483 - Paket Corp - August 06, 2019

An FDA inspection of Paket Corp, a drug manufacturer and repacker in Chicago, IL, revealed significant deficiencies in their quality control unit and overall adherence to cGMP. The firm lacked numerous essential written procedures for critical operations such as annual product reviews, QA release, master batch records, process validation, OOS investigations, and change management. Additionally, issues were noted with cleaning procedures, documentation of production activities, and the product recall system.