FDA Inspection 1234377 — AMCO International Manufacturing & Design, Inc.
The FDA completed an inspection of AMCO International Manufacturing & Design, Inc. on Mar 20, 2024 in Brooklyn, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 20, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Brooklyn, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |