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AMD Medicom Inc. FDA Inspection Record

FEI 3002677549 · Inspections, Form 483s, warning letters and import refusals

AMD Medicom Inc. is an FDA-registered facility (FEI 3002677549) located in Pointe-Claire, Montreal Quebec, CA. RegDataLab tracks 1 FDA inspection at this facility.

What FDA found at this site

Latest inspection
Dec 13, 2012: 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
Recalls as the recalling firm
3, latest May 8, 2026
Import refusals
4

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
Dec 13, 2012Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Design input - Lack of or inadequate procedures (21 CFR 820.30(c))
Design plans- updated (21 CFR 820.30(b))
Design verification - Lack of or inadequate procedures (21 CFR 820.30(f))
and 1 more

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.

DateClassRecallProduct and reason
May 8, 2026Class IIZ-2458-2026Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C… and 1 more product
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during…
Dec 21, 2023Class IIZ-1146-2024HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448) and 2 more products
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of…
Oct 11, 2019Class IIZ-0494-2020MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040 and 1 more product
Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually…

FDA record score

7 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.

4 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-2458-2026, this FEI as the recalling firmMay 8, 20264 x 14
Class II recall Z-1146-2024, this FEI as the recalling firmDec 21, 20234 x 0.62.4
Class II recall Z-0494-2020, this FEI as the recalling firmOct 11, 20194 x 0.251
Inspection classified VAIDec 13, 201210 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 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
AMD Medicom Inc.
Location
Pointe-Claire, Montreal Quebec (CA)
Source
device

Import refusals

FDA data resources

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