FDA Inspection 1044364 — Auro PR Inc
The FDA completed an inspection of Auro PR Inc on March 15, 2018 in Caguas, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 15, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Caguas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |