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BIOTEQUE AMERICA, INC. FDA Inspection Record

FEI 3024860690 · Inspections, Form 483s, warning letters and import refusals

BIOTEQUE AMERICA, INC. is an FDA-registered facility (FEI 3024860690) located in Richardson, TX, US. RegDataLab tracks 1 FDA inspection at this facility.

What FDA found at this site

Latest inspection
Apr 23, 2025: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
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

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.

DateResultWhat FDA cited
Apr 23, 2025Voluntary Action Indicated (VAI)GUDID Information required for unique device identification. (21 CFR 830.310(b))
Lack of or inadequate procedures (21 CFR 820.100(a))
Maintenance schedule, Lack of or inadequate schedule (21 CFR 820.70(g)(1))
Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))
and 2 more

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Bioteque America, Inc
Location
Richardson, TX (US)
Source
device

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.