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Biomedical Regenerative GF, LLC — FDA Facility Profile

FEI 3014172516

Biomedical Regenerative GF, LLC is an FDA-inspected facility (FEI 3014172516) located in Boca Raton, FL, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
May 30, 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
May 30, 2023Voluntary Action Indicated (VAI)Design control - no procedures (21 CFR 820.30(a))
DMR - not or inadequately maintained (21 CFR 820.181)
Management representative (21 CFR 820.20(b)(3))
Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))
and 2 more

Facility details

Company
Biomedical Regenerative GF, LLC
Location
Boca Raton, FL (US)
Source
inspections

FDA data resources

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