FDA Inspection
Hercon Pharmaceuticals, LLCHercon Pharmaceuticals, LLC – FDA Inspection, Jul 23, 2012
Record Details
This FDA Inspection record concerns Hercon Pharmaceuticals, LLC, with an inspection on July 23, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hercon Pharmaceuticals, LLC
- Inspection Date
- July 23, 2012
- Product Type
- Drugs
View Company Profile
ID · 676ccbb4-2a18-4057-8992-e0a3a96e7a08
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 793319
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 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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