Thumb Oilseed Producers' Cooperative

Form 483 issued February 23, 2010 · Ubly, Michigan

Inspection
Jan 28 – Feb 23, 2010
Observations
5
Pages
4
FEI number
3004252720

In short: On February 23, 2010, FDA issued a Form 483 with 5 observations to Thumb Oilseed Producers' Cooperative in Ubly, Michigan (FEI 3004252720) after an inspection that ran Jan 28 – Feb 23, 2010. The investigators were Lisa J. Renick, Lisa M. Thursam, Margaret N. Persich, Michele L. Forster and Rohn R. Robertson. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.35 (sanitary operations).

At a glance

5 of 5 observations on this 483 concern food cgmp / preventive controls.

Food CGMP / preventive controls5

Most cited: 21 CFR 110.35 (3×) · 110.80 (2×)

What FDA observed

Preview: the opening words of each observation

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

  1. 01

    Food which has become contaminated to the extent of being adulterated within the meaning of the…

  2. 02

    Failure to manufacture, package, and store foods under conditions and controls…

  3. 03

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

  4. 04

    Failure to maintain buildings, fixtures, or other physical facilities…

1 more observation

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 Thumb Oilseed Producers' Cooperative?

FDA listed 5 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 Thumb Oilseed Producers' Cooperative?

Lisa J. Renick, Lisa M. Thursam, Margaret N. Persich, Michele L. Forster and Rohn R. Robertson are named on this Form 483, for the inspection of Jan 28 – Feb 23, 2010. Each investigator has a profile showing what they cite most.

When was Thumb Oilseed Producers' Cooperative inspected by FDA?

The inspection ran Jan 28 – Feb 23, 2010, and the Form 483 is dated February 23, 2010.

How do I get the full Form 483 for Thumb Oilseed Producers' Cooperative?

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