FDA Inspection
MSD International GmbH (Singapore Branch)MSD International GmbH (Singapore Branch) – FDA Inspection, Oct 12, 2018
Record Details
This FDA Inspection record concerns MSD International GmbH (Singapore Branch), with an inspection on October 12, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 4d4dc6eb-c83c-415e-82fb-649f03e60e3d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1068494
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
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Other FDA inspections of MSD International GmbH (Singapore Branch)
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 30, 2025 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 20, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 5, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for MSD International GmbH (Singapore Branch)
- FDA Inspection 1275234 - 2025-05-30
- FDA Inspection 972325 - 2016-05-20
- FDA Inspection 900218 - 2014-09-05
- FDA Inspection 780641 - 2012-04-26
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