FDA Inspection
Athenex Pharma Solutions, LLCAthenex Pharma Solutions, LLC – FDA Inspection, Aug 28, 2019
Record Details
This FDA Inspection record concerns Athenex Pharma Solutions, LLC, with an inspection on August 28, 2019, issued by the New York District Office, covering human drugs.
- Office
- New York District Office
- Person
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ID · f478d761-3a34-479b-a79c-3a3869df1596
Inspection Facts
- Inspection number
- 1100698
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Athenex Pharma Solutions, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 13, 2017 | VAI | New York District Office | Drug Quality Assurance |
| September 3, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Athenex Pharma Solutions, LLC
- FDA Inspection 1179659 - 2022-09-16
- FDA Inspection 1034742 - 2017-12-13
- FDA Inspection 893756 - 2014-09-03
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