Company
United StatesGenlabs Corporation, Chino, CA – FDA Inspections
Inspection records and compliance data for Genlabs Corporation in Chino, California. 6 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected December 09, 2021.
Company Profile
This profile covers Genlabs Corporation based in Chino, California, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 4
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected March 12, 2009. Last inspected December 9, 2021.
Most cited issue areas
- Equipment Design, Size and Location3 inspections
- Written procedures not established/followed3 inspections
- Cleaning / Sanitizing / Maintenance2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 9, 2021 | OAI | Human Drugs · Drug Quality Assurance | 1158526 |
| July 21, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1018698 |
| December 11, 2015 | VAI | Human Drugs · Drug Quality Assurance | 953128 |
| December 9, 2011 | VAI | Human Drugs · Drug Quality Assurance | 760697 |
| November 10, 2010 | VAI | Human Drugs · Drug Quality Assurance | 697468 |
| March 12, 2009 | NAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 569623 |
FDA documents
Form 483s (1)
Warning Letters (1)
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Genlabs Corporation
FEI Number
1000125638
Address
5568 Schaefer Ave, Chino, California 91710, United States
Country
United States
ID: d064f8a7-2b33-40d0-b1c9-02465de0f974