FDA Inspection
Hercon Pharmaceuticals, LLCHercon Pharmaceuticals, LLC – FDA Inspection, Apr 28, 2017
Record Details
This FDA Inspection record concerns Hercon Pharmaceuticals, LLC, with an inspection on April 28, 2017, issued by the Philadelphia District Office, covering human drugs.
- People
- Cedar H. Korang-Yeboah (Issuing Officer)
- James M. Mason (Issuing Officer)
- Yubing Tang (Company Rep)
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ID · d57581d1-36dc-45d2-ad56-045f4e6aa5b9
Inspection Facts
- Inspection number
- 1012285
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.192Investigations of discrepancies, failures
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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 |
| 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 |
| 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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