FDA Inspection 1071519 — Amend Surgical, Inc.
The FDA completed an inspection of Amend Surgical, Inc. on November 9, 2018 in Alachua, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 9, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Alachua, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |