FDA Inspection
PF Consumer Healthcare BV (Puerto Rico Operations) LLCPF Consumer Healthcare BV (Puerto Rico Operations) LLC – FDA Inspection, Aug 17, 2018
Record Details
This FDA Inspection record concerns PF Consumer Healthcare BV (Puerto Rico Operations) LLC, with an inspection on August 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 17, 2018
- Product Type
- Drugs
View Company Profile
ID · 94eeb2ed-b369-4e5a-ab1f-ed3249823bd4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1063720
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)(3)Drug products-sampling procedures/specifications
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
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 |
| October 14, 2025 | Not classified | San Juan District Office | Drug Quality Assurance |
| 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 |
Other documents for PF Consumer Healthcare BV (Puerto Rico Operations) LLC
- FDA Inspection 1309332 - 2026-09-29
- FDA Inspection 1282192 - 2025-10-14
- FDA Inspection 1231508 - 2024-05-13
- FDA Inspection 1136806 - 2021-03-17
- FDA Inspection 1097892 - 2019-07-16
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