Sgarlato Med, LLC – FDA Inspection, Dec 19, 2014

Record Details

This FDA Inspection record concerns Sgarlato Med, LLC, with an inspection on December 19, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Sgarlato Med, LLC
Inspection Date: December 19, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · fe496e12-8907-45aa-a7e5-a26715c076ec

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 907533
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.181DMR - not or inadequately maintained
21 CFR 820.40Procedures not adequately established or maintained
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 820.25(a)Personnel
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.160(a)Lack of or inadequate procedures for distribution
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures

Showing 10 of 15 citations.

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Other FDA inspections of Sgarlato Med, LLC

Date	Classification	Office	Project area
December 29, 2010	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
April 5, 2010	VAI	Center for Devices and Radiological Health	Compliance: Devices