Wholesome Soy Products, Inc.

Form 483 issued October 23, 2014 · Chicago, Illinois

Inspection
Oct 23, 2014
Observations
12
Pages
7
FEI number
3009495734

In short: On October 23, 2014, FDA issued a Form 483 with 12 observations to Wholesome Soy Products, Inc. in Chicago, Illinois (FEI 3009495734) after an inspection that ran Oct 23, 2014. The investigators were Chad J. Whitwell, Derek Golezowski, Joshua M. Adams and Rafael Padilla. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.35 (sanitary operations).

At a glance

12 of 12 observations on this 483 concern food cgmp / preventive controls.

Food CGMP / preventive controls12

Most cited: 21 CFR 110.35 (6×) · 110.40 (3×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Listeria monocytegenes was detected in the raw ready-to-eat sprout processing environment and in…

  2. 02

    Employee practices allow for potential contamination of food contact…

  3. 03

    Equipment and utensils not…

  4. 04

    Cleaning practices are not…

8 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 Wholesome Soy Products, Inc.?

FDA listed 12 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 Wholesome Soy Products, Inc.?

Chad J. Whitwell, Derek Golezowski, Joshua M. Adams and Rafael Padilla are named on this Form 483, for the inspection of Oct 23, 2014. Each investigator has a profile showing what they cite most.

When was Wholesome Soy Products, Inc. inspected by FDA?

The inspection ran Oct 23, 2014, and the Form 483 is dated October 23, 2014.

How do I get the full Form 483 for Wholesome Soy Products, Inc.?

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.

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