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FDA Inspection
•Teco Diagnostics, Inc.•April 26, 2010

Teco Diagnostics, Inc. – FDA Inspection, Apr 26, 2010

Record Details

This FDA Inspection record concerns Teco Diagnostics, Inc., with an inspection on April 26, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company
Teco Diagnostics, Inc.
Inspection Date
April 26, 2010
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · b888c2fe-7b9d-423b-9cd6-340a5417bb05

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
660426
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

13
  1. 21 CFR 820.198(a)General
  2. 21 CFR 820.20(b)(1)Responsibility, authority and independence
  3. 21 CFR 820.100(a)(3)Identification of actions needed
  4. 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
  5. 21 CFR 820.150(a)Storage procedures to avoid release of unsuitable product
  6. 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
  7. 21 CFR 820.184Lack of or inadequate DHR procedures
  8. 21 CFR 820.30(a)Design control - no procedures
  9. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
  10. 21 CFR 820.75(a)Documentation

Showing 10 of 13 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Teco Diagnostics, Inc.

5
DateClassificationOfficeProject area
February 5, 2026Not classifiedLos Angeles District Office
October 27, 2021NAICenter for Devices and Radiological HealthCompliance: Devices
May 9, 2018VAICenter for Devices and Radiological HealthCompliance: Devices
April 4, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
October 14, 2011OAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Teco Diagnostics, Inc.
  • FDA Inspection 1309600 - 2026-02-05
  • FDA Inspection 1156041 - 2021-10-27
  • FDA Inspection 1052273 - 2018-05-09
  • FDA Inspection 831948 - 2013-04-04
  • FDA Inspection 753658 - 2011-10-14

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