FDA Inspection
MSD International GmbHMSD International GmbH – FDA Inspection, Mar 24, 2023
Record Details
This FDA Inspection record concerns MSD International GmbH, with an inspection on March 24, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 19964be8-c161-4112-a6c2-bd437b4e4ad5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1203427
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MSD International GmbH
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 20, 2017 | Not classified | Office of Inspections and Investigations | |
| May 16, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 15, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 5, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for MSD International GmbH
- FDA Inspection 1172999 - 2022-05-13
- FDA Inspection 1025371 - 2017-06-20
- FDA Inspection 837995 - 2013-05-16
- FDA Inspection 823114 - 2013-03-15
- FDA Inspection 725047 - 2011-05-05
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