Rehabtronics Inc. – FDA Inspection, Feb 26, 2015

Record Details

This FDA Inspection record concerns Rehabtronics Inc., with an inspection on February 26, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company: Rehabtronics Inc.
Inspection Date: February 26, 2015
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 309cd28c-faab-41c2-901d-ed0482f90e78

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 916001
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.30(f)Design verification - output does not meet input requirement
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.198(e)Records of complaint investigation
21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
21 CFR 820.184DHR content
21 CFR 806.20(a)Records not kept

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Other FDA inspections of Rehabtronics Inc.

Date	Classification	Office	Project area
July 13, 2023	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
September 28, 2018	Not classified	Office of Inspections and Investigations
August 8, 2013	OAI	Center for Devices and Radiological Health	Compliance: Devices