Company
United StatesEndotec, Inc., Santa Fe Springs, CA – FDA Inspections
Inspection records and compliance data for Endotec, Inc. in Santa Fe Springs, California. 5 FDA inspections on record (4 OAI), 2 Form 483s, last inspected December 19, 2017.
Company Profile
This profile covers Endotec, Inc. based in Santa Fe Springs, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 4
- VAI
- 1
- NAI
- 0
- Form 483s
- 2
- Warning letters
- 0
First inspected May 29, 2009. Last inspected December 19, 2017.
Most cited issue areas
- Documentation3 inspections
- Purchasing controls, Lack of or inadequate procedures3 inspections
- Design Validation - Risk analysis not performed/inadequate2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 19, 2017 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1036515 |
| October 14, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 991826 |
| September 7, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 743659 |
| January 19, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 706996 |
| May 29, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 585102 |
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
Endotec, Inc.
FEI Number
3004553437
Address
14525 Valley View Ave Ste H, Santa Fe Springs, California 90670, United States
Country
United States
ID: db3ee6a3-e86b-4cb9-ab17-eeff33ebcfe5