FDA Inspection 871149 - Max Mobility LLC - March 27, 2014

Record Details

This FDA Inspection record concerns Max Mobility LLC, with an inspection on March 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Max Mobility LLC
Inspection Date: March 27, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 58ab335c-644b-4a48-97dd-910c508bc351

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 871149
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.80(e)Documentation
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.30(e)Design review - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.22Quality Audit/Reaudit - conducted
21 CFR 820.198(b)Rationale documented for no investigation
21 CFR 820.30(g)Design validation - software validation documentation

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Other FDA inspections of Max Mobility LLC

Date	Classification	Office	Project area
April 16, 2026	Not classified	New Orleans District Office	Compliance: Devices
December 7, 2023	VAI	Center for Devices and Radiological Health	Compliance: Devices
November 7, 2017	VAI	Center for Devices and Radiological Health	Compliance: Devices
April 24, 2015	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices