Form 483

Specialty Commodities Inc. Form 483, 2010-08-23

FDA issued a Form 483 to Specialty Commodities Inc. on 2010-08-23 with 2 public-safe observations.

483· Form 483 issued2 observations

Specialty Commodities Inc. · Stockton, United States · Issued August 23, 2010

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.

23 Aug 2010
21 CFR 110.80(a)(2)

Pasteurization or other adequate treatment

Cited by Courtney R Bolton, Krystina M Jackson

23 Aug 2010
21 CFR 110.80(b)(13)

Filling, assembling, packing controls

Cited by Courtney R Bolton, Krystina M Jackson

Inspected site

SCSpecialty Commodities Inc.Stockton, United States

Inspection team

CRCourtney R Bolton

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(13)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