FDA Inspection 614771 — Fine Surgical Instruments, Inc.
The FDA completed an inspection of Fine Surgical Instruments, Inc. on Sep 23, 2009 in Hempstead, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 23, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hempstead, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3200 | 21 CFR 820.40(a) | Document locations, Dissemination, etc. |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 4189 | 21 CFR 820.198(a) | General |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |