Atlas

Form 483

Specialty Co Pack Form 483, 2011-10-18

FDA issued a Form 483 to Specialty Co Pack on 2011-10-18 with 2 public-safe observations.

483· Form 483 issued2 observations

Specialty Co Pack · Ontario, United States · Issued October 18, 2011

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.

18 Oct 2011
21 CFR 108.25(c)(2)

Process filing

Cited by Kimberly M Lichter

18 Oct 2011
21 CFR 110.20(a)(1)

Harborage areas

Cited by Kimberly M Lichter

Inspected site

SCSpecialty Co PackOntario, United States

Inspection team

KMKimberly M Lichter

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)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