Form 483

SIG, Inc Form 483, 2010-07-15

FDA issued a Form 483 to SIG, Inc on 2010-07-15 with 3 public-safe observations.

483· Form 483 issued3 observations

SIG, Inc · Roseville, United States · Issued July 15, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

15 Jul 2010
21 CFR 110.35(b)(2)

Storage requirements

Cited by Michael E Cimaglio, Rhonda L Mecl

15 Jul 2010
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Michael E Cimaglio, Rhonda L Mecl

15 Jul 2010
21 CFR 110.35(d)

Failure to clean - general

Cited by Michael E Cimaglio, Rhonda L Mecl

Inspected site

SISIG, IncRoseville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x

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