FDA Inspection
Polygen Pharmaceuticals Inc.Polygen Pharmaceuticals Inc. – FDA Inspection, Dec 18, 2017
Record Details
This FDA Inspection record concerns Polygen Pharmaceuticals Inc., with an inspection on December 18, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Alice S. Tsao (FDA Associated Person)
- Jay T. Wong (Issuing Officer)
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ID · db9a03de-763e-40f3-a107-b08d41abc5b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1036340
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Polygen Pharmaceuticals Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 29, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Polygen Pharmaceuticals Inc.
- FDA Inspection 919209 - 2015-03-24
- FDA Inspection 894579 - 2014-08-29
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