FDA Inspection 960323 — Canyon Formulations LLC
The FDA completed an inspection of Canyon Formulations LLC on January 26, 2016 in Pittsburg, CA. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 26, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pittsburg, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |