FDA Inspection 737145 — Hercon Pharmaceuticals, LLC
The FDA completed an inspection of Hercon Pharmaceuticals, LLC on July 26, 2011 in Emigsville, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 26, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Emigsville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4386 | 21 CFR 211.198(b) | Written complaint record to be maintained at facility |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |