Company
United StatesSOFIE Co. dba SOFIE, Somerset, NJ – FDA Inspections
Inspection records and compliance data for SOFIE Co. dba SOFIE in Somerset, New Jersey. 5 FDA inspections on record, 1 Form 483, last inspected January 20, 2023.
Company Profile
This profile covers SOFIE Co. dba SOFIE based in Somerset, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 14, 2010. Last inspected January 20, 2023.
Most cited issue areas
- Adequate controls (general)1 inspection
- Before implementing new procedure establish and document accuracy etc.1 inspection
- Correction of problems1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 20, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1195181 |
| February 28, 2018 | Not classified | Human Drugs | 1048176 |
| June 24, 2015 | NAI | Human Drugs · Drug Quality Assurance | 931454 |
| February 28, 2012 | VAI | Human Drugs · Drug Quality Assurance | 769657 |
| September 14, 2010 | VAI | Human Drugs · Drug Quality Assurance | 680504 |
FDA documents
Form 483s (1)
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Company Information
Name
SOFIE Co. dba SOFIE
FEI Number
3005705951
Address
110 Clyde Rd Ste 1, Somerset, New Jersey 08873, United States
Country
United States
ID: d7ef92ce-c94f-4719-9dcc-b0b3d3aee158