FDA Inspection 1107385 — Zydus Hospira Oncology Private Ltd.
The FDA completed an inspection of Zydus Hospira Oncology Private Ltd. on October 22, 2019 in Ahmedabad. 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
- October 22, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ahmedabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |