FDA Inspection 766713 — Gulf Fiberoptics, Inc.
The FDA completed an inspection of Gulf Fiberoptics, Inc. on February 3, 2012 in Oldsmar, FL. 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
- February 3, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oldsmar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |