Diasol, Inc – FDA Inspection, May 28, 2010

Record Details

This FDA Inspection record concerns Diasol, Inc, with an inspection on May 28, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Diasol, Inc
Inspection Date: May 28, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · ec6e18ca-b055-4d71-a69a-b13948794cf6

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 664275
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.100(a)(2)Investigation
21 CFR 820.25(b)Training records
21 CFR 820.72(a)Equipment control activity documentation
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.184DHR content
21 CFR 820.184(a)DHR content - manufacturing dates
21 CFR 820.100(a)Lack of or inadequate procedures

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Other FDA inspections of Diasol, Inc

Date	Classification	Office	Project area
August 19, 2025	OAI	Denver District Office	Compliance: Medical Devices
February 28, 2024	VAI	Center for Devices and Radiological Health	Compliance: Devices
June 28, 2021	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
September 28, 2018	Not classified	Denver District Office	Postmarket Assurance: Devices
June 21, 2017	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices