Form 483

Setton Pistachio of Terra Bella, Inc. Form 483, 2011-03-30

FDA issued a Form 483 to Setton Pistachio of Terra Bella, Inc. on 2011-03-30 with 4 public-safe observations.

483· Form 483 issued4 observations

Setton Pistachio of Terra Bella, Inc. · Terra Bella, United States · Issued March 30, 2011

Overview

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

Inspectional observations

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

30 Mar 2011
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Helen J Hamaoka, Ligia M Sanders, Lillian C Lopez

30 Mar 2011
21 CFR 110.20(b)(2)

Contamination with microorganisms, chemicals, filth, etc.

Cited by Helen J Hamaoka, Ligia M Sanders, Lillian C Lopez

30 Mar 2011
21 CFR 110.40(c)

Non food-contact equipment in processing area

Cited by Helen J Hamaoka, Ligia M Sanders, Lillian C Lopez

30 Mar 2011
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Helen J Hamaoka, Ligia M Sanders, Lillian C Lopez

Inspected site

SPSetton Pistachio of Terra Bella, Inc.Terra Bella, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.40(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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