FDA Inspection 554863 — Prime Dental Manufacturing, Inc.
The FDA completed an inspection of Prime Dental Manufacturing, Inc. on December 22, 2008 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 22, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3163 | 21 CFR 820.184(c) | Quantity released |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 3382 | 21 CFR 820.198(e)(8) | Reply to complainant |
| 3682 | 21 CFR 820.70(d) | Implementing Personnel Procedures, Health, Cleanliness. |