FDA Inspection 865518 — AJENAT PHARMACEUTICALS LLC
The FDA completed an inspection of AJENAT PHARMACEUTICALS LLC on February 3, 2014 in Largo, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 3, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2420 | 21 CFR 211.198(a) | Quality Control Review |