FDA Inspection
Hercon Pharmaceuticals, LLCHercon Pharmaceuticals, LLC – FDA Inspection, Aug 26, 2016
Record Details
This FDA Inspection record concerns Hercon Pharmaceuticals, LLC, with an inspection on August 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hercon Pharmaceuticals, LLC
- Inspection Date
- August 26, 2016
- Product Type
- Drugs
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ID · af215795-5ed5-45de-8d33-4bdd2235fa72
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983439
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.160(a)Lab controls established, including changes
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Other FDA inspections of Hercon Pharmaceuticals, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 28, 2017 | Not classified | Philadelphia District Office | Drug Quality Assurance |
| July 23, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 17, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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