FDA Inspection 871503 — AMO Puerto Rico Manufacturing, Inc.
The FDA completed an inspection of AMO Puerto Rico Manufacturing, Inc. on March 26, 2014 in Anasco, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 26, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Anasco, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3109 | 21 CFR 820.70(d) | Personnel requirements, Lack of or inadequate requirements |