FDA Inspection 637938 — Gulf Fiberoptics, Inc.
The FDA completed an inspection of Gulf Fiberoptics, Inc. on January 12, 2010 in Oldsmar, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 12, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Oldsmar, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3268 | 21 CFR 820.80(b) | Incoming inspection, testing, verification |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |