FDA Inspection
SOFGEN PHARMACEUTICALS LLCSOFGEN PHARMACEUTICALS LLC – FDA Inspection, Jan 20, 2017
Record Details
This FDA Inspection record concerns SOFGEN PHARMACEUTICALS LLC, with an inspection on January 20, 2017, issued by the Florida District Office, covering human drugs.
- Office
- Florida District Office
- People
- Ileana Barreto-Pettit (Issuing Officer)
- Ivis L. Negron Torres (Issuing Officer)
- Jennifer L. Huntington (FDA Associated Person)
- Jingbo Xiao (FDA Associated Person)
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ID · bfd80be2-441e-40e2-90ca-9697437c8cb4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1001551
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.68(b)Backup data not assured as exact and complete
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Other FDA inspections of SOFGEN PHARMACEUTICALS LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 18, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1028977 - 2017-10-18
- FDA Inspection 844635 - 2013-08-16
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