Diasol, Inc – FDA Inspection, Feb 28, 2011

Record Details

This FDA Inspection record concerns Diasol, Inc, with an inspection on February 28, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Diasol, Inc
Inspection Date: February 28, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 7b3bceaa-36d3-4096-9c2b-2e9c4c5b1ec9

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 714206
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
21 CFR 820.75(a)Documentation
21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements

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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