FDA Inspection 929518 — Heritage Pharmaceuticals Inc
The FDA completed an inspection of Heritage Pharmaceuticals Inc on May 27, 2015 in East Brunswick, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 27, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- East Brunswick, NJ (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6829 | 21 CFR 314.80(c)(2) | Failure to report non-alert ADEs |
| 6830 | 21 CFR 314.80(c)(2) | Interval |
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |
| 6833 | 21 CFR 314.80(c)(2)(ii)(A) | Incomplete periodic safety report |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |