FDA Inspection
Sofie Co.Sofie Co. – FDA Inspection, Sep 3, 2025
Record Details
This FDA Inspection record concerns Sofie Co., with an inspection on September 3, 2025, issued by the Kansas City District Office, covering human drugs.
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ID · 726b4450-535b-4206-883f-a6fe8a8caf72
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1280383
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 212.50Adequate controls (general)
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Other FDA inspections of Sofie Co.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 15, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 12, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Sofie Co.
- FDA Inspection 1076910 - 2019-01-22
- FDA Inspection 966471 - 2016-01-15
- FDA Inspection 839403 - 2013-07-12
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