FDA Inspection 1247761 — Felix Generics Private Limited
The FDA completed an inspection of Felix Generics Private Limited on Aug 27, 2024 in Dhar. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 27, 2024
- Fiscal Year
- 2024
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Dhar (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |