Form 483

DOH Central Pharmacy Form 483, 2009-07-30

FDA issued a Form 483 to DOH Central Pharmacy on 2009-07-30 with 5 public-safe observations.

483· Form 483 issued5 observations

DOH Central Pharmacy · Tallahassee, United States · Issued July 30, 2009

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

30 Jul 2009
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Courtney A Gilbert

30 Jul 2009
21 CFR 211.125(f)

Procedures Written and Followed

Cited by Courtney A Gilbert

30 Jul 2009
21 CFR 211.150

Written distribution procedure

Cited by Courtney A Gilbert

30 Jul 2009
21 CFR 211.186(a)

Written procedures followed

Cited by Courtney A Gilbert

30 Jul 2009
21 CFR 211.192

Quality control unit review of records

Cited by Courtney A Gilbert

Inspected site

DCDOH Central PharmacyTallahassee, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.125(f)Cited across public-safe Form 483 observations1x
21 CFR 211.150Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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