Biomat USA, Inc FDA Inspections, 483s & Warning Letters (FEI 1038382)

What FDA found at this site

Latest inspection: Apr 4, 2025: No Action Indicated (NAI)
Inspections on record: 6 (6 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: 7, latest Jan 25, 2013

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
Apr 4, 2025	No Action Indicated (NAI)	No citations listed
Jul 11, 2019	No Action Indicated (NAI)	No citations listed
Mar 2, 2016	No Action Indicated (NAI)	No citations listed
Jan 16, 2014	No Action Indicated (NAI)	No citations listed
May 4, 2012	No Action Indicated (NAI)	No citations listed
Dec 11, 2009	No Action Indicated (NAI)	No citations listed

Recalls

Newest first. 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 25, 2013	Class III	B-1182-13	Source Plasma Blood product, collected from a donor whose arm inspection was not documented, was distributed.
Aug 24, 2012	Class III	B-0100-13	Source Plasma Blood products, collected from a donor who was previously deferred, were distributed.
Aug 14, 2012	Class II	B-0103-13	Source Plasma Blood product, collected from a donor with a history of incarceration, was distributed.
Mar 9, 2011	Class II	B-0637-13	Source Plasma Blood products, collected from a donor who was previously deferred, were distributed.
Apr 30, 2004	Class II	B-0956-6	Source Plasma Blood products, Blood products, collected from a donor who was previously permanently deferred, were distributed.
Mar 29, 2001	Class II	B-0933-6	Source Plasma Blood product, with an elevated ALT result, was distributed.
Mar 29, 2001	Class II	B-0938-6	Source Plasma Blood product, which tested negative for the antibody to hepatitis C virus (anti-HCV), but was collected from a donor who subsequently…

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.

5 records behind this number

Record	Date	Points x age weight
Class II recall B-0103-13, this FEI as the recalling firm	Aug 14, 2012	10 years or older, so it adds no points
Class II recall B-0637-13, this FEI as the recalling firm	Mar 9, 2011	10 years or older, so it adds no points
Class II recall B-0956-6, this FEI as the recalling firm	Apr 30, 2004	10 years or older, so it adds no points
Class II recall B-0933-6, this FEI as the recalling firm	Mar 29, 2001	10 years or older, so it adds no points
Class II recall B-0938-6, this FEI as the recalling firm	Mar 29, 2001	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

Reviewing Biomat USA, Inc as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Biomat USA, Inc yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company: Biomat USA, Inc
Location: Asheville, NC (US)
Source: inspections

Biomat USA, Inc FDA Inspection Record