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EVOLUTION DEVICES, INC. — FDA Facility Profile

FEI 3030418885

EVOLUTION DEVICES, INC. is an FDA-registered facility (FEI 3030418885) located in San Francisco, CA, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Apr 15, 2026: 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

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
Apr 15, 2026Voluntary Action Indicated (VAI)Product realization risk management processes not documented (ISO 13485:2016 Clause 7.1)
Procedures for purchasing process not documented (ISO 13485:2016 Clause 7.4.1)
Procedures for monitoring and measuring equipment requirements not documented (ISO 13485:2016 Clause 7.6)
Complaint handling procedures lack required elements (ISO 13485:2016 Clause 8.2.2)
and 3 more

Facility details

Company
EVOLUTION DEVICES, INC
Location
San Francisco, CA (US)
Source
device

FDA data resources

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