Customed, Inc. – FDA Inspection, Jul 31, 2014

Record Details

This FDA Inspection record concerns Customed, Inc., with an inspection on July 31, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Customed, Inc.
Inspection Date: July 31, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 2e7d3625-d0ee-46f4-96a2-c3b24bb5c8aa

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 890465
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 820.100(b)Documentation
21 CFR 820.130Packaging
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.150Lack of or inadequate procedures for storage.
21 CFR 820.198(e)Records of complaint investigation
21 CFR 820.70(d)Personnel requirements, Lack of or inadequate requirements
21 CFR 820.70(i)Documentation of software validation
21 CFR 806.20(a)Records not kept
21 CFR 803.17Lack of Written MDR Procedures

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Other FDA inspections of Customed, Inc.

Date	Classification	Office	Project area
October 4, 2024	Not classified	San Juan District Office
April 18, 2023	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
September 30, 2019	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
September 21, 2018	VAI	Center for Devices and Radiological Health	Compliance: Devices
August 31, 2016	VAI	Center for Devices and Radiological Health	Compliance: Devices