FDA 483 - PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC - October 14, 2025
Discuss this record with AI
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.
An FDA inspection of PF Consumer Healthcare B.V. (Puerto Rico Operational, LLC in Guayama, PR, a drug manufacturer, revealed significant deficiencies in quality control and reporting. The firm failed to timely submit a Field Alert Report for out-of-specification drug batches and did not thoroughly investigate a recurring peeling label defect that could obscure critical drug information. Additionally, the inspection found that equipment cleaning procedures lacked proper risk assessments to prevent potential contamination.
- Inspection Date
- October 14, 2025
- Product Type
- Drugs
ID · 143bc0aa-0cb3-4ea3-bf68-40ff9ff126af