FDA Inspection
Medsource PharmaceuticalsMedsource Pharmaceuticals – FDA Inspection, Dec 5, 2019
Record Details
This FDA Inspection record concerns Medsource Pharmaceuticals, with an inspection on December 5, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Medsource Pharmaceuticals
- Inspection Date
- December 5, 2019
- Product Type
- Drugs
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ID · d491d5ce-3fe5-4de8-8e6d-e1d15ae892c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1111872
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medsource Pharmaceuticals
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 10, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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