FDA Inspection 1110013 — Atlas Analytical Inc.
The FDA completed an inspection of Atlas Analytical Inc. on November 14, 2019 in Brooksville, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 14, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brooksville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |