FDA Inspection
Sofie Co dba SofieSofie Co dba Sofie – FDA Inspection, Jul 25, 2025
Record Details
This FDA Inspection record concerns Sofie Co dba Sofie, with an inspection on July 25, 2025, issued by the Baltimore District Office, covering human drugs.
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ID · 9a2591b4-4fc2-4877-b648-1b3870f57398
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1276824
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 212.70(c)Conform to specs prior to release
- 21 CFR 212.20(e)Written QA procedures established, followed
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Other FDA inspections of Sofie Co dba Sofie
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 3, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 23, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 1, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 11, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sofie Co dba Sofie
- FDA Inspection 1073264 - 2018-12-03
- FDA Inspection 924228 - 2015-01-23
- FDA Inspection 817083 - 2013-02-01
- FDA Inspection 675342 - 2010-08-11
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