FDA EIR - The Procter & Gamble Manufacturing Company - March 10, 2023

The Procter & Gamble Manufacturing Company in Greensboro, NC, underwent a comprehensive FDA inspection from March 6 to March 10, 2023. This current Good Manufacturing Practices (cGMP) inspection, conducted under Compliance Program 7356.002 for Drug Manufacturing Inspections, evaluated the firm's operations as an OTC liquid drug manufacturer and a re-packager/re-labeler of tablet and capsule OTC drugs. The assessment covered critical areas including quality, facilities, equipment, materials, production, packaging, labeling, and laboratory controls. While previous inspection observations from 2017 related to process validation and complaint procedures had been adequately addressed, the recent inspection resulted in two new observations cited on Form FDA 483. The primary violations included the failure to take representative samples of each shipment and lot of components for testing or examination, and the failure to accurately document written production and process control procedures at the time they were performed. Management was informed that these findings could lead to violations of the Federal Food, Drug, and Cosmetic Act, potentially warranting legal action. The company's management committed to submitting a formal response to the FDA's observations within 15 business days, outlining their planned corrective measures.