FDA Inspection 881606 — Atlas Pharmaceuticals, LLC
The FDA completed an inspection of Atlas Pharmaceuticals, LLC on May 30, 2014 in Phoenix, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 30, 2014
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4364 | 21 CFR 211.176 | Failing to test for penicillin cross-contamination |