FDA Inspection 1207365 — Auro PR Inc
The FDA completed an inspection of Auro PR Inc on May 31, 2023 in Caguas, 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
- May 31, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Caguas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |