Kasel Associates Industries, Inc.

Form 483 issued September 28, 2012 · Denver, Colorado

Inspection
Sep 19 – Sep 28, 2012
Observations
8
Pages
9
FEI number
1000373073

In short: On September 28, 2012, FDA issued a Form 483 with 8 observations to Kasel Associates Industries, Inc. in Denver, Colorado (FEI 1000373073) after an inspection that ran Sep 19 – Sep 28, 2012. The investigators were Andrew J. Gonzales, Jennifer A. Baker, Kathryn M. Mogen, Kristen E. Szenderski and Laura B. Kennedy. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.35 (sanitary operations).

At a glance

8 of 8 observations on this 483 concern food cgmp / preventive controls.

Food CGMP / preventive controls8

Most cited: 21 CFR 110.35(a) (2×)

What FDA observed

Preview: the opening words of each observation
  1. 01

    Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects…

  2. 02

    Effective measures are not being taken to exclude pests from the processing areas and protect against…

  3. 03

    Failure to take effective measures to protect against the inclusion of metal and…

  4. 04

    Failure to take effective measures to protect finished food from…

4 more observations

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

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Kasel Associates Industries, Inc.?

FDA listed 8 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 110.35 (sanitary operations). The opening words of each observation are shown on this page.

Who inspected Kasel Associates Industries, Inc.?

Andrew J. Gonzales, Jennifer A. Baker, Kathryn M. Mogen, Kristen E. Szenderski and Laura B. Kennedy are named on this Form 483, for the inspection of Sep 19 – Sep 28, 2012. Each investigator has a profile showing what they cite most.

When was Kasel Associates Industries, Inc. inspected by FDA?

The inspection ran Sep 19 – Sep 28, 2012, and the Form 483 is dated September 28, 2012.

How do I get the full Form 483 for Kasel Associates Industries, Inc.?

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