FDA Inspection 1270445 — Ovesco Endoscopy Usa, Inc.
The FDA completed an inspection of Ovesco Endoscopy Usa, Inc. on May 22, 2025 in Cary, NC. 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
- May 22, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cary, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |