FDA Inspection 752331 — Canyon Formulations LLC
The FDA completed an inspection of Canyon Formulations LLC on November 16, 2011 in Pittsburg, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 16, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pittsburg, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |