FDA Inspection
Sofie Co.Sofie Co. – FDA Inspection, Jan 15, 2016
Record Details
This FDA Inspection record concerns Sofie Co., with an inspection on January 15, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Sofie Co.
- Inspection Date
- January 15, 2016
- Product Type
- Drugs
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ID · 0d4fda48-d7a0-40bd-90c3-b9e54bf4afc0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 966471
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 212.20(e)Written QA procedures established, followed
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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 22, 2019 | 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 1076910 - 2019-01-22
- FDA Inspection 839403 - 2013-07-12
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