Company
United StatesCortex Manufacturing Inc., Byhalia, MS – FDA Inspections
Inspection records and compliance data for Cortex Manufacturing Inc. in Byhalia, Mississippi. 5 FDA inspections on record, 2 Form 483s, last inspected September 19, 2024.
Company Profile
This profile covers Cortex Manufacturing Inc. based in Byhalia, Mississippi, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected May 23, 2011. Last inspected September 19, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1249659 |
| January 25, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1038630 |
| April 1, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 923054 |
| January 15, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 814187 |
| May 23, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 727209 |
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
Cortex Manufacturing Inc.
FEI Number
3008706707
Address
7753 Highway 72, Byhalia, Mississippi 38611, United States
Country
United States
ID: 6a8cda79-2855-47c5-b63b-4b78678508fa