FDA Inspection
Cortechs Labs, Inc.Cortechs Labs, Inc. – FDA Inspection, Aug 5, 2010
Record Details
This FDA Inspection record concerns Cortechs Labs, Inc., with an inspection on August 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cortechs Labs, Inc.
- Inspection Date
- August 5, 2010
- Product Type
- Devices
View Company Profile
ID · e804151a-b1be-44cc-8a58-3c4a684005d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 675385
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.20(c)Management review dates
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cortechs Labs, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 26, 2026 | Not classified | Los Angeles District Office | |
| January 24, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 24, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 31, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cortechs Labs, Inc.
- FDA Inspection 1309204 - 2026-02-26
- FDA Inspection 1196101 - 2023-01-24
- FDA Inspection 841277 - 2013-07-24
- FDA Inspection 727014 - 2011-05-31
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