FDA Inspection 1032021 — Septodont Inc.
The FDA completed an inspection of Septodont Inc. on November 22, 2017 in Louisville, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 22, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Louisville, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |