FDA-Inspected Site

Regenerative Biologics Inc.

10 FDA inspections are on record for Regenerative Biologics Inc. in Alachua, United States.

Clean· No action indicated

Alachua, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-11-18.

At a glance

Inspections

10

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 Nov 2025BiologicsClean
13 Apr 2023BiologicsClean
4 Feb 2020 – 6 Feb 2020Biologics483View 483 →
14 Aug 2017 – 15 Aug 2017BiologicsClean
14 Apr 2015 – 16 Apr 2015BiologicsClean
23 Apr 2013 – 1 May 2013Biologics483View 483 →
14 Jun 2011Not recordedClean
5 Nov 2007Not recordedClean
1 Apr 2004Not recordedClean
21 Mar 2002Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

6 Feb 2020
21 CFR 1271.50(b)(1)

Donor screening standards

Cited by Barbara T Carmichael

6 Feb 2020
21 CFR 1271.50(b)(1)

Donor screening standards

Cited by Barbara T Carmichael

1 May 2013
21 CFR 1271.160(b)(4)

Training of personnel

Cited by Barbara T Carmichael

Investigators

FDA investigators tied to this site in the record.

Valerie J Grecek -Trinh1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1271.50(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 1271.160(b)(4)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Regenerative Biologics Inc.'s 2 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat