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Aztex Enterprises Ltd. FDA Inspection Record

FEI 3003516782 · Inspections, Form 483s, warning letters and import refusals

Aztex Enterprises Ltd. is an FDA-inspected facility (FEI 3003516782) located in Burlington, CA. RegDataLab tracks 1 FDA inspection and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Jun 13, 2017: Official Action Indicated (OAI)
Inspections on record
1 (1 OAI)
Last OAI inspection
Jun 13, 2017
Warning letters
1 listed by FDA for this FEI, latest Oct 23, 2017
Import refusals
7

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 13, 2017Official Action Indicated (OAI)GMP Training Frequency (21 CFR 211.25(a))
Procedures are written, and followed (21 CFR 211.130)
Prepared for each batch, include complete information (21 CFR 211.188)
Procedures to be written and followed (21 CFR 211.198(a))
and 1 more

FDA record score

15 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.

2 records behind this number
RecordDatePoints x age weightAdds
Warning letter on FDA's dashboard, which does not show close-outsOct 23, 201730 x 0.257.5
Inspection classified OAIJun 13, 201730 x 0.257.5

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
Aztex Enterprises Ltd.
Location
Burlington (CA)
Source
inspections

Compliance actions

Import refusals

FDA data resources

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