FDA Inspection
SOFIE Co. dba SOFIESOFIE Co. dba SOFIE – FDA Inspection, Oct 28, 2025
Record Details
This FDA Inspection record concerns SOFIE Co. dba SOFIE, with an inspection on October 28, 2025, issued by the Dallas District Office, covering human drugs.
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ID · f23fa115-173f-44cf-b3a9-5ba539fae69c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1288954
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 212.10Personnel not qualified
- 21 CFR 212.50Adequate controls (general)
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
- 21 CFR 212.20(d)Determination need for investigation
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Other FDA inspections of SOFIE Co. dba SOFIE
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 4, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 6, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SOFIE Co. dba SOFIE
- FDA Inspection 999635 - 2017-01-04
- FDA Inspection 977923 - 2016-05-06
- FDA Inspection 800995 - 2012-09-27
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