FDA Inspection 949113 — Discus Dental LLC
The FDA completed an inspection of Discus Dental LLC on November 23, 2015 in Ontario, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 23, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ontario, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 10022 | 21 CFR 310.305(a) | Failure to develop written procedures |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1848 | 21 CFR 211.84(d)(5) | Examination for Filth/Insect/Extraneous Material |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 4576 | 21 CFR 211.192 | No written record of investigation |