FDA Inspection 1142703 — AMCO International Manufacturing & Design, Inc.
The FDA completed an inspection of AMCO International Manufacturing & Design, Inc. on May 27, 2021 in Brooklyn, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 27, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Brooklyn, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |