FDA Inspection
Cortex Manufacturing Inc.Cortex Manufacturing Inc. – FDA Inspection, Jan 25, 2018
Record Details
This FDA Inspection record concerns Cortex Manufacturing Inc., with an inspection on January 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c40a0721-d2eb-4350-b4b7-caf820909af7
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1038630
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Cortex Manufacturing Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2024 | VAI | New Orleans District Office | Compliance: Medical Devices |
| April 1, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 23, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cortex Manufacturing Inc.
- FDA Inspection 1249659 - 2024-09-19
- FDA Inspection 923054 - 2015-04-01
- FDA Inspection 814187 - 2013-01-15
- FDA Inspection 727209 - 2011-05-23
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