FDA Inspection 1313566 — SOFIE Co. dba SOFIE
The FDA completed an inspection of SOFIE Co. dba SOFIE on April 21, 2026 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 21, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21373 | 21 CFR 212.30(b) | Equipment procedures |