Home / Facilities / 3003749234

BATRIK MEDICAL MANUFACTURING INC. FDA Inspection Record

FEI 3003749234 · Inspections, Form 483s, warning letters and import refusals

BATRIK MEDICAL MANUFACTURING INC. is an FDA-registered facility (FEI 3003749234) located in Lachine Quebec, CA. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Jul 16, 2015: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Jun 27, 2013
Warning letters
1 listed by FDA for this FEI, latest Sep 23, 2013
Import refusals
2

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
Jul 16, 2015Voluntary Action Indicated (VAI)No citations listed
Jun 27, 2013Official Action Indicated (OAI)Buildings (21 CFR 820.70(f))
DHR content (21 CFR 820.184)
Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
Lack of or inadequate process validation (21 CFR 820.75(a))

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 15, 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.

3 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIJul 16, 201510 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsSep 23, 201310 years or older, so it adds no points0
Inspection classified OAIJun 27, 201310 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

Reviewing BATRIK MEDICAL MANUFACTURING 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 BATRIK MEDICAL MANUFACTURING 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
Batrik Medical Mfg., Inc.
Location
Lachine Quebec (CA)
Source
device

Compliance actions

Import refusals

FDA data resources

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