FDA Inspection 752513 — Jerome Stevens Pharmaceuticals, Inc.
The FDA completed an inspection of Jerome Stevens Pharmaceuticals, Inc. on November 22, 2011 in Bohemia, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 22, 2011
- Fiscal Year
- 2012
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Bohemia, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4330 | 21 CFR 211.130(e) | Packaging line inspection documentation |
| 8909 | 21 CFR 314.81(b)(2)(ii) | Distribution data |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |