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Heraeus Medical Components, SRL — FDA Facility Profile

FEI 3013666336

Heraeus Medical Components, SRL is an FDA-registered facility (FEI 3013666336) located in Guadalupe Cartago, CR. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Aug 3, 2023: 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
Aug 3, 2023Voluntary Action Indicated (VAI)Quality audits - auditor independence (21 CFR 820.22)
Documentation (21 CFR 820.100(b))
Production processes (21 CFR 820.70(a))
Environmental control Lack of or inadequate procedures (21 CFR 820.70(c))
and 1 more

Facility details

Company
Heraeus Medical Components, Srl
Location
Guadalupe Cartago (CR)
Source
device

FDA data resources

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