FDA Inspection
SOFGEN PHARMACEUTICALS LLCSOFGEN PHARMACEUTICALS LLC – FDA Inspection, Oct 18, 2017
Record Details
This FDA Inspection record concerns SOFGEN PHARMACEUTICALS LLC, with an inspection on October 18, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Ileana Barreto-Pettit (Issuing Officer)
- Jennifer L. Huntington (FDA Associated Person)
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ID · b611ada5-c5b2-44f4-9bba-055823533b9c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028977
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of SOFGEN PHARMACEUTICALS LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 20, 2017 | OAI | Florida District Office | Generic Drug Evaluation |
| August 16, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for SOFGEN PHARMACEUTICALS LLC
- FDA Inspection 1001551 - 2017-01-20
- FDA Inspection 844635 - 2013-08-16
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