Company
United StatesPF Consumer Healthcare BV (Puerto Rico Operations) LLC, Guayama, PR – FDA Inspections
Inspection records and compliance data for PF Consumer Healthcare BV (Puerto Rico Operations) LLC in Guayama, Puerto Rico. 14 FDA inspections on record, 2 Form 483s, last inspected September 29, 2026.
Company Profile
This profile covers PF Consumer Healthcare BV (Puerto Rico Operations) LLC based in Guayama, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 14
- OAI
- 0
- VAI
- 9
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 30, 2009. Last inspected September 29, 2026.
Most cited issue areas
- Failure to meet specifications2 inspections
- Investigations of discrepancies, failures2 inspections
- Annual visual exams of drug products1 inspection
FDA inspections (14)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 29, 2026 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1309332 |
| October 14, 2025 | Not classified | Human Drugs · Drug Quality Assurance | 1282192 |
| May 13, 2024 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1231508 |
| March 17, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1136806 |
| July 16, 2019 | NAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 1097892 |
| August 17, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1063720 |
| October 25, 2016 | NAI | Human Drugs · Drug Quality Assurance | 996282 |
| November 17, 2014 | VAI | Human Drugs · Drug Quality Assurance | 908081 |
| July 11, 2012 | VAI | Human Drugs · Drug Quality Assurance | 790127 |
| April 29, 2011 | VAI | Human Drugs · Drug Quality Assurance | 721973 |
| March 8, 2011 | VAI | Human Drugs · Drug Quality Assurance | 713162 |
| February 5, 2010 | VAI | Human Drugs · Drug Quality Assurance | 645138 |
| December 11, 2009 | VAI | Human Drugs · Drug Quality Assurance | 633926 |
| April 30, 2009 | NAI | Human Drugs · Drug Quality Assurance | 579090 |
FDA documents
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Company Information
Name
PF Consumer Healthcare BV (Puerto Rico Operations) LLC
FEI Number
3007343300
Address
State Rd No. 3 Km. 143.8, Guayama, Puerto Rico 00784, United States
Country
United States
ID: 33236699-aeca-4971-9634-68019839e6e8