Form 483

Threeline Imports, Inc. Form 483, 2009-12-16

FDA issued a Form 483 to Threeline Imports, Inc. on 2009-12-16 with 2 public-safe observations.

483· Form 483 issued2 observations

Threeline Imports, Inc. · Brooklyn, United States · Issued December 16, 2009

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

16 Dec 2009
21 CFR 123.12(a)(2)

Importer verification

Cited by Anthony R Rauert, Ryan J Aguillon

16 Dec 2009
21 CFR 123.12(c)

Lack of records

Cited by Anthony R Rauert, Ryan J Aguillon

Inspected site

TIThreeline Imports, Inc.Brooklyn, United States

Inspection team

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