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Sterimax, Inc. FDA Inspection Record

FEI 3011394370 · Inspections, Form 483s, warning letters and import refusals

Sterimax, Inc. is an FDA-inspected facility (FEI 3011394370) located in Oakville, CA. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Mar 6, 2020: 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
Import refusals
1

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
Mar 6, 2020Voluntary Action Indicated (VAI)Equipment Design, Size and Location (21 CFR 211.63)
Computer control of master formula records (21 CFR 211.68(b))
input/output verification (21 CFR 211.68(b))
Test methods (21 CFR 211.165(e))
and 1 more

Facility details

Company
Sterimax, Inc.
Location
Oakville (CA)
Source
inspections

Import refusals

FDA data resources

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