Summit Medical, LLC – FDA Inspection, Nov 10, 2016

Record Details

This FDA Inspection record concerns Summit Medical, LLC, with an inspection on November 10, 2016, issued by the Center for Devices and Radiological Health, covering devices.

Company: Summit Medical, LLC
Inspection Date: November 10, 2016
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Christine I. Shaw (Company Rep)

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ID · 3a685e30-86fb-4299-874c-c0022cef493b

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 992583
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(d)Design output - Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.80(e)Documentation

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Other FDA inspections of Summit Medical, LLC

Date	Classification	Office	Project area
May 14, 2018	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
March 9, 2018	VAI	Center for Devices and Radiological Health	Bioresearch Monitoring
March 4, 2015	NAI	Center for Devices and Radiological Health	Compliance: Devices
May 5, 2014	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
January 28, 2013	OAI	Center for Devices and Radiological Health	Compliance: Devices