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Form 483

Regenerative Biologics Inc. Form 483, 2013-05-01

FDA issued a Form 483 to Regenerative Biologics Inc. on 2013-05-01 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Regenerative Biologics Inc. · Alachua, United States · Issued May 1, 2013

Overview

  • 1 public-safe observation is 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.

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

Training of personnel

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 1271.160(b)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

Every observation in full, 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