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Anexa Biomedical, Inc. — FDA Facility Profile

FEI 3027590916

Anexa Biomedical, Inc. is an FDA-registered facility (FEI 3027590916) located in North Richland Hills, TX, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Jun 10, 2026: 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
Jun 10, 2026Voluntary Action Indicated (VAI)External party controls do not include written quality agreements (ISO 13485:2016 Clause 4.1.5)
Product realization risk management processes not documented (ISO 13485:2016 Clause 7.1)
Records of validation of processes and necessary actions not maintained (ISO 13485:2016 Clause 7.5.6)
Corrective action not taken (ISO 13485:2016 Clause 8.5.2)

Facility details

Company
Anexa Biomedical, Inc.
Location
North Richland Hills, TX (US)
Source
device

FDA data resources

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