Atlas

Form 483

LifeSouth Community Blood Centers, Inc Form 483, 2013-07-12

FDA issued a Form 483 to LifeSouth Community Blood Centers, Inc on 2013-07-12 with 4 public-safe observations.

483· Form 483 issuedBiologics4 observations

LifeSouth Community Blood Centers, Inc · Gainesville, United States · Issued July 12, 2013

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are 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 Jul 2013
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Barbara T Carmichael

12 Jul 2013
21 CFR 820.30(a)

Design control - no procedures

Cited by Barbara T Carmichael

12 Jul 2013
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Barbara T Carmichael

12 Jul 2013
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Barbara T Carmichael

Inspected site

LCLifeSouth Community Blood Centers, IncGainesville, United States

Inspection team

BTBarbara T Carmichael

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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