FDA Inspection
MSD International GmbH (Singapore Branch)MSD International GmbH (Singapore Branch) – FDA Inspection, Mar 16, 2017
Record Details
This FDA Inspection record concerns MSD International GmbH (Singapore Branch), with an inspection on March 16, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a303b760-dc4b-4cf2-8079-b447a5e751bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1008993
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of MSD International GmbH (Singapore Branch)
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2026 | Not classified | Office of Inspections and Investigations | |
| September 26, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 17, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 5, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 16, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for MSD International GmbH (Singapore Branch)
- FDA Inspection 1299886 - 2026-01-23
- FDA Inspection 1109025 - 2019-09-26
- FDA Inspection 925072 - 2015-03-17
- FDA Inspection 824017 - 2013-03-05
- FDA Inspection 674861 - 2010-07-16
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