FDA Inspection 1085238 — Hercon Pharmaceuticals, LLC
The FDA completed an inspection of Hercon Pharmaceuticals, LLC on April 5, 2019 in Emigsville, PA. 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
- April 5, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Emigsville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4353 | 21 CFR 211.160(b)(4) | Instruments, apparatus, et. al. not meeting specs |