FDA Inspection 830521 — Discus Dental LLC
The FDA completed an inspection of Discus Dental LLC on May 6, 2013 in Ontario, CA. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 6, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ontario, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |