FDA EIR - The Procter & Gamble Manufacturing Company - August 15, 2016

The Procter & Gamble Company's Phoenix, AZ facility underwent an unannounced cGMP drug performance goal inspection by the FDA from August 11 to August 15, 2016. The inspection, conducted under the regulatory framework of CPG 7356.002 (Drug Manufacturing Inspections) and subject to the Food, Drug, and Cosmetic Act, including 21 CFR Part 210 and 211, focused on the manufacturing of over-the-counter (OTC) psyllium fiber powder. Inspectors reviewed various operational areas, including manufacturing, packaging, quality systems (annual product review, deviations, change control), material handling, supplier qualification, and laboratory systems. Notable aspects included the firm's reacquisition by P&G in 2014, the ongoing construction of new warehouse space, and the recent installation and validation of a new water generation system and air dryers. Crucially, at the conclusion of this comprehensive inspection, no significant Current Good Manufacturing Practice (cGMP) deficiencies were identified. Consequently, the FDA did not issue an FDA-483, indicating no formal violations were observed. No samples were collected, and no refusals were encountered. The closeout meeting reinforced the expectation for the company to continuously adhere to regulatory compliance.