FDA Inspection 1195331 — Cronus Pharma Specialities India Pvt Ltd
The FDA completed an inspection of Cronus Pharma Specialities India Pvt Ltd on Jan 18, 2023 in Hyderabad. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 18, 2023
- Fiscal Year
- 2023
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Hyderabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |