FDA Inspection
Hercon Pharmaceuticals, LLCHercon Pharmaceuticals, LLC – FDA Inspection, Jul 26, 2011
Record Details
This FDA Inspection record concerns Hercon Pharmaceuticals, LLC, with an inspection on July 26, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hercon Pharmaceuticals, LLC
- Inspection Date
- July 26, 2011
- Product Type
- Drugs
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ID · 428c8ad4-8084-4362-8fbf-ff5b1ebd20a8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 737145
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.198(b)Written complaint record to be maintained at facility
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
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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 |
| August 26, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 23, 2012 | 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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