Company
United StatesCortechs Labs, Inc., San Diego, CA – FDA Inspections
Inspection records and compliance data for Cortechs Labs, Inc. in San Diego, California. 5 FDA inspections on record, last inspected February 26, 2026.
Company Profile
This profile covers Cortechs Labs, Inc. based in San Diego, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 5, 2010. Last inspected February 26, 2026.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 26, 2026 | Not classified | Medical Devices & Rad Health | 1309204 |
| January 24, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1196101 |
| July 24, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 841277 |
| May 31, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 727014 |
| August 5, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 675385 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Cortechs Labs, Inc.
FEI Number
3003405980
Address
5060 Shorman Pl, Ste 240, San Diego, California 92122, United States
Country
United States
ID: be16de22-5c9d-4770-8bdb-96329fc13c4f