FDA Inspection 1160748 — Cronus Pharma Specialities India Pvt Ltd
The FDA completed an inspection of Cronus Pharma Specialities India Pvt Ltd on Jan 15, 2022 in Hyderabad. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 15, 2022
- Fiscal Year
- 2022
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Hyderabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |