FDA Inspection 606729 — Premiere 1 Dental Laboratory, LLC
The FDA completed an inspection of Premiere 1 Dental Laboratory, LLC on Aug 25, 2009 in Bradenton, FL. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 25, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bradenton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4189 | 21 CFR 820.198(a) | General |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |