FDA Inspection 1063720 — PF Consumer Healthcare BV (Puerto Rico Operations) LLC
The FDA completed an inspection of PF Consumer Healthcare BV (Puerto Rico Operations) LLC on August 17, 2018 in Guayama, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 17, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Guayama, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |