Company
United StatesSOFIE Co. dba SOFIE, Houston, TX – FDA Inspections
Inspection records and compliance data for SOFIE Co. dba SOFIE in Houston, Texas. 4 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected October 28, 2025.
Company Profile
This profile covers SOFIE Co. dba SOFIE based in Houston, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 1
First inspected September 27, 2012. Last inspected October 28, 2025.
Most cited issue areas
- Adequate controls (general)1 inspection
- Determination need for investigation1 inspection
- Orderly handling, prevention of mix-ups, prevention of contamination1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 28, 2025 | VAI | Human Drugs · Drug Quality Assurance | 1288954 |
| January 4, 2017 | NAI | Human Drugs · Drug Quality Assurance | 999635 |
| May 6, 2016 | VAI | Human Drugs · Drug Quality Assurance | 977923 |
| September 27, 2012 | NAI | Human Drugs · Drug Quality Assurance | 800995 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
SOFIE Co. dba SOFIE
FEI Number
3003932395
Address
8285 El Rio St Ste 160, Houston, Texas 77054, United States
Country
United States
ID: 2788a42c-0f99-4a95-8de3-ef2e88c93110