FDA Inspection 1120136 — Jubilant Cadista Pharmaceuticals
The FDA completed an inspection of Jubilant Cadista Pharmaceuticals on February 28, 2020 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
- February 28, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yardley, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 21536 | 21 CFR 514.80(b)(1) | Applicant did not submit/submitted late 3-Day Field Alert Report or wrong format |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |