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

Source: https://www.keypedia.com/records/483/pf-consumer-healthcare-bv-puerto-rico-operations-llc/143bc0aa-0cb3-4ea3-bf68-40ff9ff126af

> FDA 483 for PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC on October 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC
- Inspection Date: 2025-10-14
- Product Type: drugs
- Office Name: San Juan District Office
- Summary: 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.

## Related Documents

- [483 - 2021-03-17](https://www.keypedia.com/records/483/pf-consumer-healthcare-bv-puerto-rico-operations-llc/40112554-5360-4660-8344-bdf559321302)

## Related Officers

- [Jose F. Velez](https://www.keypedia.com/people/jose-f-velez/0d1951e8-3aa5-48ff-bc54-1fae8a7a57c9)
- [investigator](https://www.keypedia.com/people/marian-e-ramirez/4b718b67-fee0-488c-9354-ee366d3510ad)

Company: https://www.keypedia.com/companies/pf-consumer-healthcare-bv-puerto-rico-operations-llc/33236699-aeca-4971-9634-68019839e6e8

Office: https://www.keypedia.com/offices/san-juan-district-office/27661cbf-5ba6-4c1b-9b39-4d6df63ca0e8