FDA Inspection
Medsource PharmaceuticalsMedsource Pharmaceuticals – FDA Inspection, Dec 11, 2023
Record Details
This FDA Inspection record concerns Medsource Pharmaceuticals, with an inspection on December 11, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a04eb301-fc2c-4e12-b213-a81fbfb4ce00
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224701
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Medsource Pharmaceuticals
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2019 | 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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