FDA Inspection
Cortek Endoscopy IncCortek Endoscopy Inc – FDA Inspection, Jun 16, 2015
Record Details
This FDA Inspection record concerns Cortek Endoscopy Inc, with an inspection on June 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cortek Endoscopy Inc
- Inspection Date
- June 16, 2015
- Product Type
- Devices
View Company Profile
ID · 735ec183-266a-419c-8758-bdf16b5ac5cd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 930407
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cortek Endoscopy Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 16, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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