FDA Inspection 945562 — Tools For Surgery, LLC
The FDA completed an inspection of Tools For Surgery, LLC on August 27, 2015 in Stony Brook, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 27, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Stony Brook, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |