FDA Inspection 1114389 — Gulf Fiberoptics, Inc.
The FDA completed an inspection of Gulf Fiberoptics, Inc. on December 18, 2019 in Oldsmar, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 18, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Oldsmar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |