Company
United StatesSOFIE Co. dba SOFIE, Dallas, TX – FDA Inspections
Inspection records and compliance data for SOFIE Co. dba SOFIE in Dallas, Texas. 4 FDA inspections on record, 2 Form 483s, last inspected April 21, 2026.
Company Profile
This profile covers SOFIE Co. dba SOFIE based in Dallas, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected October 22, 2013. Last inspected April 21, 2026.
Most cited issue areas
- Adequate controls (general)1 inspection
- Equipment procedures1 inspection
- Initials, signature, date1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 21, 2026 | Not classified | Human Drugs · Drug Quality Assurance | 1313566 |
| January 15, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1076429 |
| May 27, 2016 | VAI | Human Drugs · Drug Quality Assurance | 970671 |
| October 22, 2013 | VAI | Human Drugs · Drug Quality Assurance | 854064 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
SOFIE Co. dba SOFIE
FEI Number
3008486071
Address
4447 Brass Way, Dallas, Texas 75236, United States
Country
United States
ID: 3b677367-baec-43c5-8387-5939b730d8b7