FDA Inspection 775103 — AMCO International Manufacturing & Design, Inc.
The FDA completed an inspection of AMCO International Manufacturing & Design, Inc. on March 28, 2012 in Brooklyn, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 28, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Brooklyn, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |