FDA Inspection
PF Consumer Healthcare BV (Puerto Rico Operations) LLCPF Consumer Healthcare BV (Puerto Rico Operations) LLC – FDA Inspection, Oct 14, 2025
Record Details
This FDA Inspection record concerns PF Consumer Healthcare BV (Puerto Rico Operations) LLC, with an inspection on October 14, 2025, issued by the San Juan District Office, covering human drugs.
- Inspection Date
- October 14, 2025
- Product Type
- Human Drugs
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ID · 700b67d1-bb68-4bd8-8362-f08d2ea015f9
Inspection Facts
- Inspection number
- 1282192
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
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Other FDA inspections of PF Consumer Healthcare BV (Puerto Rico Operations) LLC
13| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2026 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 13, 2024 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 17, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 16, 2019 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 17, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for PF Consumer Healthcare BV (Puerto Rico Operations) LLC
- FDA Inspection 1309332 - 2026-09-29
- FDA Inspection 1231508 - 2024-05-13
- FDA Inspection 1136806 - 2021-03-17
- FDA Inspection 1097892 - 2019-07-16
- FDA Inspection 1063720 - 2018-08-17
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