FDA Inspection 565106 — Park Dental Research Corp
The FDA completed an inspection of Park Dental Research Corp on Feb 24, 2009 in Ardmore, OK. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 24, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ardmore, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3157 | 21 CFR 820.181(c) | DMR QA procedures and specifications |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |