FDA Inspection 697792 — AIAC International Pharma, LLC
The FDA completed an inspection of AIAC International Pharma, LLC on November 3, 2010 in Arecibo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 3, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Arecibo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |