Algomedica, Inc. — FDA Facility Profile

FEI 3013488109

Algomedica, Inc. is an FDA-inspected facility (FEI 3013488109) located in Sunnyvale, CA, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Mar 28, 2024: Voluntary Action Indicated (VAI)
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
Mar 28, 2024Voluntary Action Indicated (VAI)Management representative (21 CFR 820.20(b)(3))
Management review - defined interval, sufficient frequency (21 CFR 820.20(c))
Quality Audits - defined intervals (21 CFR 820.22)
Aug 22, 2019No Action Indicated (NAI)Design review - Lack of or inadequate procedures (21 CFR 820.30(e))
Lack of or inadequate procedures (21 CFR 820.100(a))
Installer records (21 CFR 820.170(b))
Management review - Lack of or inadequate procedures (21 CFR 820.20(c))
and 1 more

Facility details

Company
Algomedica, Inc.
Location
Sunnyvale, CA (US)
Source
inspections

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