FDA Inspection
Sofie Co dba SofieSofie Co dba Sofie – FDA Inspection, Dec 3, 2018
Record Details
This FDA Inspection record concerns Sofie Co dba Sofie, with an inspection on December 3, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 08096f94-1e16-4a8c-8638-9bc39013d79d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073264
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 212.20(e)Written QA procedures established, followed
- 21 CFR 212.30(a)Orderly handling, prevention of mix-ups, prevention of contamination
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Other FDA inspections of Sofie Co dba Sofie
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2025 | VAI | Baltimore District Office | 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 1276824 - 2025-07-25
- FDA Inspection 924228 - 2015-01-23
- FDA Inspection 817083 - 2013-02-01
- FDA Inspection 675342 - 2010-08-11
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