FDA Inspection
Cortex Manufacturing Inc.Cortex Manufacturing Inc. – FDA Inspection, Jan 15, 2013
Record Details
This FDA Inspection record concerns Cortex Manufacturing Inc., with an inspection on January 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cortex Manufacturing Inc.
- Inspection Date
- January 15, 2013
- Product Type
- Devices
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ID · c307a8dc-5170-419c-9c26-9f41db423e5f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 814187
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cortex Manufacturing Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2024 | VAI | New Orleans District Office | Compliance: Medical Devices |
| January 25, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 1, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1038630 - 2018-01-25
- FDA Inspection 923054 - 2015-04-01
- FDA Inspection 727209 - 2011-05-23
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