Kelyniam Global, Inc. – FDA Inspection, Jul 22, 2021

Record Details

This FDA Inspection record concerns Kelyniam Global, Inc., with an inspection on July 22, 2021, issued by the Center for Devices and Radiological Health, covering devices.

Company: Kelyniam Global, Inc.
Inspection Date: July 22, 2021
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · b2785922-1487-4303-868d-c8a0578d3320

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1146978
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 820.30(c)Design input - documentation
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 820.22Quality Audit/Reaudit - conducted
21 CFR 820.184DHR content

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Other FDA inspections of Kelyniam Global, Inc.

Date	Classification	Office	Project area
August 23, 2024	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
August 15, 2019	VAI	Center for Devices and Radiological Health	Compliance: Devices
September 25, 2018	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
May 30, 2017	OAI	Center for Devices and Radiological Health	Compliance: Devices
April 17, 2013	VAI	Center for Devices and Radiological Health	Compliance: Devices