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Image Monitoring USA Inc. — FDA Facility Profile

FEI 3014171825

Image Monitoring USA Inc. is an FDA-inspected facility (FEI 3014171825) located in Buffalo, NY, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jun 24, 2024: No Action Indicated (NAI)
Inspections on record
2 (1 VAI, 1 NAI)
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 24, 2024No Action Indicated (NAI)No citations listed
Feb 6, 2020Voluntary Action Indicated (VAI)Procedures not adequately established or maintained (21 CFR 820.40)
Training records (21 CFR 820.25(b))
Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)

Facility details

Company
Image Monitoring USA Inc.
Location
Buffalo, NY (US)
Source
inspections

FDA data resources

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