FDA Inspection 648331 — Suncoast Laboratories
The FDA completed an inspection of Suncoast Laboratories on Feb 5, 2010 in Buena Park, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Buena Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2330 | 21 CFR 820.22 | Quality audit corrective action, reaudits {see also 820.100} |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3301 | 21 CFR 820.100(a)(2) | Investigation procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |