FDA Inspection 670573 — AMO Puerto Rico Manufacturing, Inc.
The FDA completed an inspection of AMO Puerto Rico Manufacturing, Inc. on June 29, 2010 in Anasco, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 29, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Anasco, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3682 | 21 CFR 820.70(d) | Implementing Personnel Procedures, Health, Cleanliness. |
| 538 | 21 CFR 820.70(a) | Process control procedures |