X-Ray Systems, Inc. – FDA Inspection, Jun 23, 2017

Record Details

This FDA Inspection record concerns X-Ray Systems, Inc., with an inspection on June 23, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company: X-Ray Systems, Inc.
Inspection Date: June 23, 2017
Product Type: Devices
Office: Center for Devices and Radiological Health
People: Nicholas Z. Lu (Issuing Officer)
Todd Q. Dang (Issuing Officer)

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ID · aeca5cb9-e65c-4d75-8ce2-a8701dbb1963

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 1015986
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.100(b)Documentation
21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 820.22Quality Audit/Reaudit - conducted
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.30(j)Design history file
21 CFR 820.50(a)(2)Supplier oversight

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Other FDA inspections of X-Ray Systems, Inc.

Date	Classification	Office	Project area
September 3, 2026	VAI	Center for Devices and Radiological Health	Compliance: Devices
March 4, 2022	VAI	Center for Devices and Radiological Health	Compliance: Devices
September 18, 2019	VAI	Center for Devices and Radiological Health	Compliance: Devices
May 21, 2010	NAI	Center for Devices and Radiological Health	Radiation Control and Health Safety Act