FDA Inspection 937344 — Mylan Pharmaceuticals Inc.
The FDA completed an inspection of Mylan Pharmaceuticals Inc. on July 17, 2015 in San Carlos, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 17, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Carlos, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |