FDA Inspection 835523 — Septodont Inc.
The FDA completed an inspection of Septodont Inc. on June 12, 2013 in Louisville, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 12, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Louisville, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1086 | 21 CFR 211.22(b) | Adequate lab facilities not available |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |