Company
United StatesSOFIE Co, Totowa, NJ – FDA Inspections
Inspection records and compliance data for SOFIE Co in Totowa, New Jersey. 4 FDA inspections on record, 1 Form 483, last inspected August 11, 2023.
Company Profile
This profile covers SOFIE Co based in Totowa, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 27, 2012. Last inspected August 11, 2023.
Most cited issue areas
- Complaint review1 inspection
- Documentation of Non-Conforming Product Investigation1 inspection
- Labeling and product mix-ups1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 11, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1214455 |
| June 28, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1020388 |
| May 15, 2015 | VAI | Human Drugs · Drug Quality Assurance | 925779 |
| September 27, 2012 | NAI | Human Drugs · Drug Quality Assurance | 800942 |
FDA documents
Form 483s (1)
EIRs (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
SOFIE Co
FEI Number
3008415560
Address
60 Commerce Way Rm H, Totowa, New Jersey 07512, United States
Country
United States
ID: d06f8036-2bc5-4dbb-885b-341a1ecbb82a