FDA Inspection 815420 — AJENAT PHARMACEUTICALS LLC
The FDA completed an inspection of AJENAT PHARMACEUTICALS LLC on January 7, 2013 in Largo, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 7, 2013
- Fiscal Year
- 2013
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 6830 | 21 CFR 314.80(c)(2) | Interval |