FDA Inspection 715587 — Jubilant Cadista Pharmaceuticals
The FDA completed an inspection of Jubilant Cadista Pharmaceuticals on March 23, 2011 in Yardley, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 23, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yardley, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1891 | 21 CFR 211.165(f) | Failing drug products not rejected |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |