FDA Inspection
Sofie Co.Sofie Co. – FDA Inspection, Jan 22, 2019
Record Details
This FDA Inspection record concerns Sofie Co., with an inspection on January 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Rita K. Vick (Issuing Officer)
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ID · ed573aa3-697b-48f1-af8b-434e34874744
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076910
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 212.20(d)Determination need for investigation
- 21 CFR 212.30(b)Equipment procedures
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Other FDA inspections of Sofie Co.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2025 | VAI | Kansas City District Office | 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 1280383 - 2025-09-03
- FDA Inspection 966471 - 2016-01-15
- FDA Inspection 839403 - 2013-07-12
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