Company
United StatesAthenex Pharma Solutions, LLC, Clarence, NY – FDA Inspections
Inspection records and compliance data for Athenex Pharma Solutions, LLC in Clarence, New York. 4 FDA inspections on record, 2 Form 483s, last inspected September 16, 2022.
Company Profile
This profile covers Athenex Pharma Solutions, LLC based in Clarence, New York, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 3, 2014. Last inspected September 16, 2022.
Most cited issue areas
- Cleaning System1 inspection
- Drug product label, outsourcer facility1 inspection
- Environmental Monitoring System1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 16, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1179659 |
| August 28, 2019 | Not classified | Human Drugs · Drug Quality Assurance | 1100698 |
| December 13, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1034742 |
| September 3, 2014 | NAI | Human Drugs · Drug Quality Assurance | 893756 |
FDA documents
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Company Information
Name
Athenex Pharma Solutions, LLC
FEI Number
3008876196
Address
11342 Main St, Clarence, New York 14031, United States
Country
United States
ID: d8bf380f-b613-4bd7-831f-33a576776e21