Guam Memorial Hosp Authority

FDA establishment 1000523688, Tamuning, Guam, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.

Inspections: 4
Official action indicated: 0
Last inspection ended: Mar 6, 2026
Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

02019

02021

02023

02025

02027

Most Cited at This Site

Inspections citing each reference

Inspections

4 inspections, newest first

Ended	Product and area	Citations	Classification
Mar 6, 2026	Biologics · Blood and Blood Products	3 cited references 21 CFR 606.100(b). Establish, maintain and follow manufacturing SOPs Written standard operating procedures including all steps to be followed in the collection and distribution of blood and blood components for allogeneic transfusion were not always followed. 21 CFR 630.40(a). Notification Failure to make reasonable attempts to notify a donor who has been deferred based on the results of tests for evidence of infection with a relevant transfusion-transmitted infection(s). 21 CFR 630.10(g)(1). Proof Of Identity Failure to obtain from the donor on the day of donation a postal address where the donor may be contacted for 8 weeks after donation.	Voluntary Action Indicated (VAI)
Sep 23, 2016	Biologics · Blood and Blood Products	None posted	Voluntary Action Indicated (VAI)
Jun 25, 2013	Biologics · Blood and Blood Products	None posted	No Action Indicated (NAI)
Aug 26, 2011	Biologics · Blood and Blood Products	4 cited references 21 CFR 600.14(a)(1). Who must report - manufacturer Failure to submit biological deviation reports. 21 CFR 606.140(a). Establishment of spec., standards, and test procedures Failure to establish scientifically sound and appropriate specifications, standards and test procedures to assure that blood and blood components are safe, pure, potent and effective. 21 CFR 606.121(h). Labeling requirements for emergency shipment Failure to include the statement, ?FOR EMERGENCY USE ONLY BY __________? on blood or blood components shipped in an emergency prior to completion of required tests. 21 CFR 606.100(b)(10). Controlling storage temperatures The standard operating procedure fails to include a written description of the storage temperatures and methods of controlling storage temperatures for all blood products and reagents	Voluntary Action Indicated (VAI)

Identifiers

FEI number: 1000523688
FDA firm profile: Data Dashboard

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters