FDA EIR - PureTek Corporation - January 30, 2020

An FDA cGMP inspection of PureTek Corporation's San Fernando facility was conducted from January 23-30, 2020, under Compliance Program 7356.002, Drug Manufacturing Inspections. The inspection covered quality, facilities/equipment, production, packaging and labeling, and laboratory systems. Two significant violations were issued to CEO Mr. Barry Pressman. The first observation noted the absence of formal bulk hold time studies for Urinary Tract Infection (UTI) drug tablets and capsules, failing to ensure drug product identity, strength, quality, and purity as required by regulatory standards. The company’s "In-Process Holding Time" procedure also did not adequately support validated bulk hold times for solid dose products. The second observation highlighted deficiencies in the "Cleaning Validation Master Protocol for Tank and Filler," specifically the lack of required approval signatures from the Quality Unit for both the completion summary and testing specifications. Management was directed to submit corrective actions to the FDA within 15 calendar days. Additionally, the report noted the continued manufacturing of prescription drug products, including Lidocaine and fluoride products, without prior FDA approval.