FDA Inspection 1239023 — Artesanales P.R. LLC
The FDA completed an inspection of Artesanales P.R. LLC on January 22, 2025 in Bayamon, PR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 22, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bayamon, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |