FDA Inspection
Athenex Pharma Solutions, LLCAthenex Pharma Solutions, LLC – FDA Inspection, Dec 13, 2017
Record Details
This FDA Inspection record concerns Athenex Pharma Solutions, LLC, with an inspection on December 13, 2017, issued by the New York District Office, covering human drugs.
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ID · c22653da-50c4-4bd9-a551-77a3449d401a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034742
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.46(b)Equipment for Environmental Control
- FDCA 503B(a)(10)Drug product label, outsourcer facility
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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 |
| August 28, 2019 | Not classified | 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 1100698 - 2019-08-28
- FDA Inspection 893756 - 2014-09-03
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