FDA Inspection 699938 — Jerome Stevens Pharmaceuticals, Inc.
The FDA completed an inspection of Jerome Stevens Pharmaceuticals, Inc. on November 23, 2010 in Bohemia, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 23, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bohemia, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1174 | 21 CFR 211.42(b) | Product flow through building is inadequate |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4418 | 21 CFR 211.42(b) | Adequate space lacking to prevent mix-ups and contamination |