Diasol, Inc – FDA Inspection, Sep 28, 2018

Record Details

This FDA Inspection record concerns Diasol, Inc, with an inspection on September 28, 2018, issued by the Denver District Office, covering medical devices & rad health.

Company: Diasol, Inc
Inspection Date: September 28, 2018
Product Type: Medical Devices & Rad Health
Office: Denver District Office
Person: Janet Pulver (FDA Associated Person)

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ID · a5a6c64a-352e-488f-8584-610343091fc3

Inspection Facts

Inspection number: 1067155
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.17Lack of Written MDR Procedures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.120Lack of or inadequate procedures for labeling
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.30(f)Design verification - documentation
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.30(j)Design history file
21 CFR 820.70(a)Process control procedures, 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
June 21, 2017	OAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
February 8, 2017	NAI	Center for Devices and Radiological Health	Compliance: Devices