Atlas

Form 483

OneBlood, Inc. Form 483, 2016-08-12

FDA issued a Form 483 to OneBlood, Inc. on 2016-08-12 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

OneBlood, Inc. · Fort Lauderdale, United States · Issued August 12, 2016

Overview

  • 3 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.

12 Aug 2016
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Barbara T Carmichael

12 Aug 2016
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Barbara T Carmichael

12 Aug 2016
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Barbara T Carmichael

Inspected site

OIOneBlood, Inc.Fort Lauderdale, United States

Inspection team

BTBarbara T Carmichael

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 3 observations

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