Company
United StatesSOFGEN PHARMACEUTICALS LLC, Miramar, FL – FDA Inspections
Inspection records and compliance data for SOFGEN PHARMACEUTICALS LLC in Miramar, Florida. 3 FDA inspections on record (1 OAI), 2 Form 483s, last inspected October 18, 2017.
Company Profile
This profile covers SOFGEN PHARMACEUTICALS LLC based in Miramar, Florida, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected August 16, 2013. Last inspected October 18, 2017.
Most cited issue areas
- Investigations of discrepancies, failures2 inspections
- Scientifically sound laboratory controls2 inspections
- Backup data not assured as exact and complete1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 18, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1028977 |
| January 20, 2017 | OAI | Human Drugs · Generic Drug Evaluation | 1001551 |
| August 16, 2013 | VAI | Foods & Cosmetics · Food Composition, Standards, Labeling and Econ | 844635 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SOFGEN PHARMACEUTICALS LLC
FEI Number
3044138844
Address
1600 Miramar Pkwy, Miramar, Florida 33025, United States
Country
United States
ID: 03a9d5f6-f33a-4183-a9ba-b68bb9d7e0a7