FDA Inspection 1058783 — A.M. Surgical, Inc.
The FDA completed an inspection of A.M. Surgical, Inc. on July 6, 2018 in Smithtown, NY. 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
- July 6, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Smithtown, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3308 | 21 CFR 820.120(a) | Remain legible |