Company

United States

North Shore Medical Center, Salem, MA – FDA Inspections

Inspection records and compliance data for North Shore Medical Center in Salem, Massachusetts. 8 FDA inspections on record, 2 Form 483s, last inspected December 13, 2024.

Company Profile

This profile covers North Shore Medical Center based in Salem, Massachusetts, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 4
NAI: 4
Form 483s: 2
Warning letters: 0

First inspected January 27, 2009. Last inspected December 13, 2024.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs2 inspections
Donor suitability procedures not followed1 inspection
Record review prior to release1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
December 13, 2024	NAI	Biologics · Blood and Blood Products	1257468
July 2, 2019	VAI	Biologics · Blood and Blood Products	1097191
March 8, 2018	VAI	Biologics · Blood and Blood Products	1047824
February 18, 2016	NAI	Biologics · Blood and Blood Products	960567
January 15, 2014	VAI	Biologics · Blood and Blood Products	864161
January 26, 2012	NAI	Biologics · Blood and Blood Products	764615
September 1, 2010	VAI	Biologics · Blood and Blood Products	678714
January 27, 2009	NAI	Biologics · Blood and Blood Products	558722

FDA documents

Form 483s (1)

Form 483s · July 2, 2019

People (1)

Alice Silva

Person

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