FDA 483 - PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC - October 14, 2025

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.