FDA Inspection
Medsource PharmaceuticalsMedsource Pharmaceuticals – FDA Inspection, Feb 10, 2017
Record Details
This FDA Inspection record concerns Medsource Pharmaceuticals, with an inspection on February 10, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 22c0161c-f145-43d4-a42e-c39f4bdce90f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009141
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.204Returned drug products with doubt cast as to safety et. al.
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures not established/followed
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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 |
| December 5, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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