Diasol, Inc – FDA Inspection, Apr 3, 2009

Record Details

This FDA Inspection record concerns Diasol, Inc, with an inspection on April 3, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Diasol, Inc
Inspection Date: April 3, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · e1e74804-91f6-4eac-be7e-6b86bd8027d9

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 574070
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.72(a)Equipment suitability & capability
21 CFR 820.70(d)Training temp work under special environmental conditions
21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.72(b)(2)Calibration documentation

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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