FDA Inspection
Teco Diagnostics, Inc.Teco Diagnostics, Inc. – FDA Inspection, May 9, 2018
Record Details
This FDA Inspection record concerns Teco Diagnostics, Inc., with an inspection on May 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7d647221-f055-4a90-9d3a-e86390c0c583
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052273
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
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Other FDA inspections of Teco Diagnostics, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2026 | Not classified | Los Angeles District Office | |
| October 27, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 4, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 14, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 26, 2010 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Teco Diagnostics, Inc.
- FDA Inspection 1309600 - 2026-02-05
- FDA Inspection 1156041 - 2021-10-27
- FDA Inspection 831948 - 2013-04-04
- FDA Inspection 753658 - 2011-10-14
- FDA Inspection 660426 - 2010-04-26
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