FDA Inspection
Viatris Pharmaceuticals LLCViatris Pharmaceuticals LLC – FDA Inspection, May 18, 2026
Record Details
This FDA Inspection record concerns Viatris Pharmaceuticals LLC, with an inspection on May 18, 2026, issued by the San Juan District Office, covering human drugs.
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ID · 4a13ccbe-d6e6-4f77-a94e-af7b329a2587
Inspection Facts
- Inspection number
- 1290796
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
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Other FDA inspections of Viatris Pharmaceuticals LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| February 17, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 26, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 26, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 19, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 11, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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