FDA Inspection 771915 — Sun Medical, Inc.
The FDA completed an inspection of Sun Medical, Inc. on Mar 12, 2012 in Quinlan, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 12, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Quinlan, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |