FDA Inspection 1136803 — Olein Recovery Corp
The FDA completed an inspection of Olein Recovery Corp on March 18, 2021 in Yabucoa, 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 18, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yabucoa, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1419 | 21 CFR 211.42(c)(8) | Released Drug Products Area |
| 4338 | 21 CFR 211.150(b) | Recall facilitation |