FDA Inspection 1019539 — Surgical Instrument Manufacturers, LLC
The FDA completed an inspection of Surgical Instrument Manufacturers, LLC on May 11, 2017 in Fenton, MO. 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
- May 11, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fenton, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |