FDA Inspection 612701 — Premium Plus Dental Supplies Inc.
The FDA completed an inspection of Premium Plus Dental Supplies Inc. on September 21, 2009 in Brooklyn, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 21, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Brooklyn, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |