FDA Inspection 652088 — AMO Puerto Rico Manufacturing, Inc.
The FDA completed an inspection of AMO Puerto Rico Manufacturing, Inc. on March 11, 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 11, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Anasco, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3381 | 21 CFR 820.198(e)(7) | Corrective action taken |
| 4189 | 21 CFR 820.198(a) | General |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |