FDA Inspection
SOFIE Co. dba SOFIESOFIE Co. dba SOFIE – FDA Inspection, Aug 28, 2025
Record Details
This FDA Inspection record concerns SOFIE Co. dba SOFIE, with an inspection on August 28, 2025, issued by the Baltimore District Office, covering human drugs.
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ID · f281f4bb-bf39-41b2-9fdc-c6b2cd5ab649
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1280292
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 212.30(b)Equipment procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SOFIE Co. dba SOFIE
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 18, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 6, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 16, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SOFIE Co. dba SOFIE
- FDA Inspection 966039 - 2016-03-18
- FDA Inspection 882139 - 2014-06-06
- FDA Inspection 794296 - 2012-08-16
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