Atlas

Form 483

Regenerative Biologics Inc. Form 483, 2020-02-06

FDA issued a Form 483 to Regenerative Biologics Inc. on 2020-02-06 with 2 public-safe observations.

483· Form 483 issuedBiologics2 observations

Regenerative Biologics Inc. · Alachua, United States · Issued February 6, 2020

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

RBRegenerative Biologics Inc.Alachua, United States

Inspection team

BTBarbara T Carmichael

Cited regulations

CFR citations associated with this Form 483.

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

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 2 observations

The source PDF, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere