Atlas

Form 483

Central Boeki U.S.A. LTD. Form 483, 2012-12-28

FDA issued a Form 483 to Central Boeki U.S.A. LTD. on 2012-12-28 with 2 public-safe observations.

483· Form 483 issued2 observations

Central Boeki U.S.A. LTD. · Long Island City, United States · Issued December 28, 2012

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

28 Dec 2012
21 CFR 123.12(a)(2)

Importer verification

Cited by Tara K Normandin

28 Dec 2012
21 CFR 123.12(c)

Lack of records

Cited by Tara K Normandin

Inspected site

CBCentral Boeki U.S.A. LTD.Long Island City, United States

Inspection team

TKTara K Normandin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.12(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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