Company
United StatesPolygen Pharmaceuticals Inc., Edgewood, NY – FDA Inspections
Inspection records and compliance data for Polygen Pharmaceuticals Inc. in Edgewood, New York. 3 FDA inspections on record, 1 Form 483, last inspected December 18, 2017.
Company Profile
This profile covers Polygen Pharmaceuticals Inc. based in Edgewood, New York, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected August 29, 2014. Last inspected December 18, 2017.
Most cited issue areas
- Calibration/Inspection/Checking not done1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 18, 2017 | VAI | Human Drugs · Generic Drug Evaluation | 1036340 |
| March 24, 2015 | VAI | Human Drugs · Drug Quality Assurance | 919209 |
| August 29, 2014 | VAI | Human Drugs · Drug Quality Assurance | 894579 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Polygen Pharmaceuticals Inc.
FEI Number
3008383084
Address
41 Mercedes Way Unit 17, Edgewood, New York 11717, United States
Country
United States
ID: d7df0d1f-787a-4629-b096-255e664d26ef