FDA Inspection 1068959 — Atlas Bioscience
The FDA completed an inspection of Atlas Bioscience on Oct 17, 2018 in Tucson, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 17, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |