St. Mary's Regional Hospital, Grand Junction, CO – FDA Inspections

Inspection records and compliance data for St. Mary's Regional Hospital in Grand Junction, Colorado. 9 FDA inspections on record (1 OAI), last inspected September 05, 2024.

Company Profile

This profile covers St. Mary's Regional Hospital based in Grand Junction, Colorado, United States.

FDA Inspection History

FDA inspections: 9
OAI: 1
VAI: 6
NAI: 1
Unclassified: 1
Form 483s: 0
Warning letters: 0

First inspected May 11, 2009. Last inspected September 5, 2024.

Most cited issue areas

Establish, maintain and follow manufacturing SOPs3 inspections
Following manufacturer"s instructions2 inspections
Person performing, test results, interpretation2 inspections

FDA inspections (9)

Date	Result	FDA center(s)	Insp. #
September 5, 2024	Not classified	Biologics	1249087
September 14, 2023	NAI	Biologics · Blood and Blood Products	1219955
August 30, 2018	VAI	Biologics · Blood and Blood Products	1067775
August 5, 2016	VAI	Biologics · Blood and Blood Products	985842
June 28, 2013	VAI	Biologics · Blood and Blood Products	838220
June 15, 2012	OAI	Biologics · Blood and Blood Products	787023
March 18, 2011	VAI	Biologics · Blood and Blood Products	716130
September 7, 2010	VAI	Biologics · Blood and Blood Products	680953
May 11, 2009	VAI	Biologics · Blood and Blood Products	597360

FDA documents

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

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