FDA Inspection
Heritage Pharmaceuticals IncHeritage Pharmaceuticals Inc – FDA Inspection, May 27, 2015
Record Details
This FDA Inspection record concerns Heritage Pharmaceuticals Inc, with an inspection on May 27, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Heritage Pharmaceuticals Inc
- Inspection Date
- May 27, 2015
- Product Type
- Drugs
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ID · f261afef-9af1-4473-88bd-dcff7160b395
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 929518
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(c)(2)(ii)(A)Incomplete periodic safety report
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(c)(2)Interval
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Other FDA inspections of Heritage Pharmaceuticals Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 3, 2016 | NAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
Other documents for Heritage Pharmaceuticals Inc
- FDA Inspection 1037529 - 2017-12-14
- FDA Inspection 989875 - 2016-10-03
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