FDA 483 - PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC - March 17, 2021

This FDA Form 483 was issued to PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC, a solid dosage manufacturer in Guayama, PR, following an inspection from March 1-17, 2021. The inspection revealed significant deficiencies in the firm's quality system, including inadequate complaint investigations, unsound laboratory controls for product testing, failures in the stability program, and improper handling of reserve samples. Additionally, the firm failed to submit a required NDA-Field Alert Report for distributed batches that did not meet specifications.