FDA Inspection 1048779 — Zydus Hospira Oncology Private Ltd.
The FDA completed an inspection of Zydus Hospira Oncology Private Ltd. on April 12, 2018 in Ahmedabad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ahmedabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |