FDA Inspection
Sofgen Pharmaceuticals LLCSofgen Pharmaceuticals LLC – FDA Inspection, Dec 11, 2019
Record Details
This FDA Inspection record concerns Sofgen Pharmaceuticals LLC, with an inspection on December 11, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sofgen Pharmaceuticals LLC
- Inspection Date
- December 11, 2019
- Product Type
- Drugs
View Company Profile
ID · 6f58abf7-f35e-4cce-ae77-8fec8e5476d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1112405
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.80(d)Status of Each Lot Identified
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sofgen Pharmaceuticals LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 2, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 16, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sofgen Pharmaceuticals LLC
- FDA Inspection 944979 - 2015-10-02
- FDA Inspection 844635 - 2013-08-16
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