Company
United StatesStason Pharmaceuticals, Inc., Irvine, CA – FDA Inspections
Inspection records and compliance data for Stason Pharmaceuticals, Inc. in Irvine, California. 12 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected April 13, 2021.
Company Profile
This profile covers Stason Pharmaceuticals, Inc. based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 1
- VAI
- 8
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 1
First inspected December 16, 2009. Last inspected April 13, 2021.
Most cited issue areas
- Procedures not in writing, fully followed2 inspections
- Interval1 inspection
- Specification description of sample/testing1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 13, 2021 | VAI | Human Drugs · Drug Quality Assurance | 1140029 |
| October 25, 2019 | OAI | Human Drugs · Drug Quality Assurance | 1109969 |
| August 24, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1067952 |
| June 14, 2017 | VAI | Human Drugs · Generic Drug Evaluation | 1014137 |
| March 8, 2016 | VAI | Human Drugs · Drug Quality Assurance | 960658 |
| January 22, 2015 | VAI | Human Drugs · Drug Quality Assurance | 911418 |
| December 18, 2013 | VAI | Human Drugs · Drug Quality Assurance | 859439 |
| February 8, 2013 | NAI | Human Drugs · Drug Quality Assurance | 818014 |
| July 12, 2012 | NAI | Human Drugs · Drug Quality Assurance | 790419 |
| March 18, 2011 | VAI | Human Drugs · Drug Quality Assurance | 717438 |
| August 24, 2010 | VAI | Human Drugs · Bioresearch Monitoring | 677200 |
| December 16, 2009 | VAI | Human Drugs · Drug Quality Assurance | 636336 |
FDA documents
Warning Letters (1)
People (5)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Stason Pharmaceuticals, Inc.
FEI Number
1000160561
Address
11 Morgan, Irvine, California 92618, United States
Country
United States
ID: f8669d38-d60b-4f0c-856a-ac536c422fae