Company
United StatesCortek Endoscopy Inc, Wauconda, IL – FDA Inspections
Inspection records and compliance data for Cortek Endoscopy Inc in Wauconda, Illinois. 3 FDA inspections on record, 1 Form 483, last inspected October 16, 2018.
Company Profile
This profile covers Cortek Endoscopy Inc based in Wauconda, Illinois, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected August 16, 2011. Last inspected October 16, 2018.
Most cited issue areas
- Design control - no procedures3 inspections
- Lack of Written MDR Procedures2 inspections
- DHR - not or inadequately maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 16, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1069062 |
| June 16, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 930407 |
| August 16, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 739709 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cortek Endoscopy Inc
FEI Number
3003816595
Address
260 Jamie Ln Ste D, Wauconda, Illinois 60084, United States
Country
United States
ID: c3f13b8b-0b84-4fc3-b085-250878922ace