FDA Inspection 1064773 — ATLAS R&D Inc
The FDA completed an inspection of ATLAS R&D Inc on Sep 6, 2018 in Cambridge. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 6, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cambridge (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4322 | 21 CFR 211.101(d) | Component release checked by 2nd person |