FDA Inspection 699000 — Eagle Endoscopic, Inc.
The FDA completed an inspection of Eagle Endoscopic, Inc. on Nov 15, 2010 in Jacksonville, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 15, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |