FDA Intel

Setton Pistachio of Terra Bella, Inc.

Form 483 issued April 30, 2009 · Terra Bella, California

Inspection
Mar 26 – Apr 30, 2009
Investigators
Estefania Fernandez· Joanne M. Fukuda· Karen J. Bak
Observations
7
Pages
5
FEI number
2939582

In short: On April 30, 2009, FDA issued a Form 483 with 7 observations to Setton Pistachio of Terra Bella, Inc. in Terra Bella, California (FEI 2939582) after an inspection that ran Mar 26 – Apr 30, 2009. The investigators were Estefania Fernandez, Joanne M. Fukuda and Karen J. Bak. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.80 (processes and controls).

At a glance

7 of 7 observations on this 483 concern food cgmp / preventive controls.

Food CGMP / preventive controls7

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 110.80(b)(2)

    Failure to manufacture, package, and store foods under conditions and controls necessary to minimize the potential…

  2. 02
    21 CFR 110.80(a)(2)

    Raw materials which contain levels of microorganisms that may produce food poisoning or other disease are…

  3. 03
    21 CFR 110.20(b)(2)

    Proper precautions to protect food and food-contact surfaces from contamination with microorganisms cannot be taken because…

  4. 04
    21 CFR 110.80(b)(6)

    Failure to take effective measures to protect finished food from contamination by raw…

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Estefania Fernandez

10 documents · 2009–2015

Cites 118.4 (salmonella enteritidis (se) prevention measures) more than any other section. Most of their documents are for sites in California.

The firm

Setton Pistachio of Terra Bella, Inc. history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 110.80(b)(2)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Setton Pistachio of Terra Bella, Inc.?

FDA listed 7 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.80 (processes and controls). The opening words of each observation are shown on this page.

Who inspected Setton Pistachio of Terra Bella, Inc.?

Estefania Fernandez, Joanne M. Fukuda and Karen J. Bak are named on this Form 483, for the inspection of Mar 26 – Apr 30, 2009. Each investigator has a profile showing what they cite most.

When was Setton Pistachio of Terra Bella, Inc. inspected by FDA?

The inspection ran Mar 26 – Apr 30, 2009, and the Form 483 is dated April 30, 2009.

How do I get the full Form 483 for Setton Pistachio of Terra Bella, Inc.?

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