FDA Inspection
Cortex Manufacturing Inc.Cortex Manufacturing Inc. – FDA Inspection, Sep 19, 2024
Record Details
This FDA Inspection record concerns Cortex Manufacturing Inc., with an inspection on September 19, 2024, issued by the New Orleans District Office, covering medical devices & rad health.
- Company
- Cortex Manufacturing Inc.
- Inspection Date
- September 19, 2024
- Product Type
- Medical Devices & Rad Health
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ID · b585194b-ad9b-430a-a78c-becb35dcc42f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249659
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cortex Manufacturing Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| 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 1038630 - 2018-01-25
- FDA Inspection 923054 - 2015-04-01
- FDA Inspection 814187 - 2013-01-15
- FDA Inspection 727209 - 2011-05-23
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