FDA Inspection 1060039 — Forge Medical Inc.
The FDA completed an inspection of Forge Medical Inc. on July 18, 2018 in Bethlehem, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 18, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bethlehem, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |