Company
United StatesChalgren Enterprises, Inc., Gilroy, CA – FDA Inspections
Inspection records and compliance data for Chalgren Enterprises, Inc. in Gilroy, California. 4 FDA inspections on record, last inspected September 03, 2015.
Company Profile
This profile covers Chalgren Enterprises, Inc. based in Gilroy, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected June 25, 2010. Last inspected September 3, 2015.
Most cited issue areas
- Lack of or inadequate process validation3 inspections
- Document changes, review and approval, communication2 inspections
- Lack of Written MDR Procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 3, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 940407 |
| March 28, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 775186 |
| July 21, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 673672 |
| June 25, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 669414 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Chalgren Enterprises, Inc.
FEI Number
2939713
Address
380 Tomkins Ct, Gilroy, California 95020, United States
Country
United States
ID: 5448417c-cd46-43fa-8e23-4bb952978b52