Cape Cod Hospital, Hyannis, MA – FDA Inspections

Inspection records and compliance data for Cape Cod Hospital in Hyannis, Massachusetts. 8 FDA inspections on record, 1 Form 483, last inspected September 10, 2024.

Company Profile

This profile covers Cape Cod Hospital based in Hyannis, Massachusetts, United States.

FDA Inspection History

FDA inspections: 8
OAI: 0
VAI: 2
NAI: 6
Form 483s: 1
Warning letters: 0

First inspected April 7, 2009. Last inspected September 10, 2024.

Most cited issue areas

Donor Deferral2 inspections
Establish, maintain and follow manufacturing SOPs2 inspections
Donor deferral record - each location1 inspection

FDA inspections (8)

Date	Result	FDA center(s)	Insp. #
September 10, 2024	NAI	Biologics · Blood and Blood Products	1249436
November 5, 2021	NAI	Biologics · Blood and Blood Products	1157650
February 15, 2019	VAI	Biologics · Blood and Blood Products	1079428
December 29, 2016	NAI	Biologics · Blood and Blood Products	997068
October 23, 2014	NAI	Biologics · Blood and Blood Products	900700
August 14, 2012	VAI	Biologics · Blood and Blood Products	795606
July 28, 2010	NAI	Biologics · Blood and Blood Products	675919
April 7, 2009	NAI	Biologics · Blood and Blood Products	574004

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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