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Grifols Biomat USA, Inc. FDA Inspection Record

FEI 1000306163 · Inspections, Form 483s, warning letters and import refusals

Grifols Biomat USA, Inc. is an FDA-inspected facility (FEI 1000306163) located in Provo, UT, US. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection: Nov 9, 2022: No Action Indicated (NAI)
Inspections on record: 3 (3 NAI)
Last OAI inspection: None on record
Warning letters: None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm: 11, latest Jan 19, 2009

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Nov 9, 2022	No Action Indicated (NAI)	No citations listed
Mar 15, 2017	No Action Indicated (NAI)	No citations listed
Nov 15, 2011	No Action Indicated (NAI)	No citations listed

Recalls

Showing the 10 most recent of 11 recalls. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Jan 19, 2009	Class II	B-0146-13	Source Plasma Blood products, which were not quarantined subsequent to receiving information regarding high risk behavior, were distributed.
Mar 18, 2005	Class II	B-1191-6	Source Plasma Blood products, collected from an ineligible donor due to a history of intravenous drug use, were distributed.
Jan 19, 2005	Class II	B-1192-6	Source Plasma Blood products, collected from an ineligible donor due to a history of intravenous drug use, were distributed.
Jan 6, 2005	Class II	B-1452-6	Source Plasma Blood products, collected from an ineligible donor due to a history of intravenous drug use, were distributed.
Aug 20, 2004	Class II	B-1241-6	Source Plasma Blood products, which were collected from a donor who was incarcerated, were distributed.
May 21, 2004	Class II	B-1187-6	Source Plasma Blood products, collected from a donor who previously deferred by another donor center, were distributed.
Dec 22, 2003	Class II	B-1306-6	Source Plasma Blood products, collected from a donor who had not had an annual physical performed, were distributed.
Nov 12, 2003	Class II	B-0984-6	Source Plasma Blood products collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Aug 13, 2003	Class II	B-1186-6	Source Plasma Blood products, which tested negative for hepatitis, but were collected from a donor who was previously deferred for positive hepatitis…
Dec 21, 2001	Class III	B-1929-4	Source Plasma Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection…

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

9 records behind this number

Record	Date	Points x age weight
Class II recall B-0146-13, this FEI as the recalling firm	Jan 19, 2009	10 years or older, so it adds no points
Class II recall B-1191-6, this FEI as the recalling firm	Mar 18, 2005	10 years or older, so it adds no points
Class II recall B-1192-6, this FEI as the recalling firm	Jan 19, 2005	10 years or older, so it adds no points
Class II recall B-1452-6, this FEI as the recalling firm	Jan 6, 2005	10 years or older, so it adds no points
Class II recall B-1241-6, this FEI as the recalling firm	Aug 20, 2004	10 years or older, so it adds no points
Class II recall B-1187-6, this FEI as the recalling firm	May 21, 2004	10 years or older, so it adds no points
Class II recall B-1306-6, this FEI as the recalling firm	Dec 22, 2003	10 years or older, so it adds no points
Class II recall B-0984-6, this FEI as the recalling firm	Nov 12, 2003	10 years or older, so it adds no points
Class II recall B-1186-6, this FEI as the recalling firm	Aug 13, 2003	10 years or older, so it adds no points

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
Records	Last refreshed	Source as of	Status
Inspections	Nov 14, 2026	Newest record Nov 5, 2026	Current
Inspection citations	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions (warning letters, injunctions and other action types)	Nov 2, 2026	Newest record Oct 29, 2026	Current
Warning letter text	Nov 14, 2026	Newest record Nov 10, 2026	Current
Recalls (Enforcement Report)	Nov 14, 2026	Newest record Nov 11, 2026	Current
Form 483s and inspection documents	Nov 13, 2026	Newest record Nov 12, 2026	Current
Import refusals	Nov 2, 2026	Newest record Oct 22, 2026	Current

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Facility details

Company: Grifols Biomat USA, Inc.
Location: Provo, UT (US)
Source: inspections