The Procter & Gamble Manufacturing Company – FDA 483, Feb 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.
- Office
- Atlanta District Office
- Person
ID · 65e947f7-42f1-4683-ae69-237a395bcc6f
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.