FDA Inspection
PF Consumer Healthcare BV (Puerto Rico Operations) LLCPF Consumer Healthcare BV (Puerto Rico Operations) LLC – FDA Inspection, Mar 17, 2021
Record Details
This FDA Inspection record concerns PF Consumer Healthcare BV (Puerto Rico Operations) LLC, with an inspection on March 17, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 17, 2021
- Product Type
- Drugs
View Company Profile
ID · b5238471-87d2-46c6-8446-5204268dfa53
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1136806
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully 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 |
| 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 1282192 - 2025-10-14
- FDA Inspection 1231508 - 2024-05-13
- FDA Inspection 1097892 - 2019-07-16
- FDA Inspection 1063720 - 2018-08-17
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.