FDA Inspection
SOFIE Co. dba SOFIESOFIE Co. dba SOFIE – FDA Inspection, Jan 15, 2019
Record Details
This FDA Inspection record concerns SOFIE Co. dba SOFIE, with an inspection on January 15, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 626cbb81-7f76-4192-b370-00ee7bd5a150
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076429
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 212.70(e)When 30 hour rule is exceeded
- 21 CFR 212.60(g)(5)Initials, signature, date
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
- 21 CFR 212.50Adequate controls (general)
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Other FDA inspections of SOFIE Co. dba SOFIE
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2026 | Not classified | Dallas District Office | Drug Quality Assurance |
| May 27, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 22, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SOFIE Co. dba SOFIE
- FDA Inspection 1313566 - 2026-04-21
- FDA Inspection 970671 - 2016-05-27
- FDA Inspection 854064 - 2013-10-22
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