FDA 483 - The Procter & Gamble Manufacturing Company - February 18, 2022

The Procter & Gamble Manufacturing Company in Browns Summit, NC, received a Form 483 with three observations related to manufacturing processes and quality control. The inspection revealed significant issues with cleaning validation and procedures for non-dedicated equipment, leading to potential product contamination. Additionally, the firm's investigations into critical consumer complaints regarding foreign objects in drug products were found to be inadequate, failing to extend to other batches or evaluate retain samples.