FDA Inspection 1257696 — Jubilant Cadista Pharmaceuticals
The FDA completed an inspection of Jubilant Cadista Pharmaceuticals on January 15, 2025 in Yardley, PA. 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
- January 15, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yardley, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |
| 3594 | 21 CFR 211.110(d) | Rejected in-process materials not quarantined |