FDA Intel

Thermo Pac, LLC

Form 483 issued June 3, 2011 · Stone Mo'untain, Georgia

Inspection
May 23 – Jun 3, 2011
Investigators
Arlyss M. Jones· Robert P. Neligan· Rory C. Burton
Observations
8
Pages
3
FEI number
1031630

In short: On June 3, 2011, FDA issued a Form 483 with 8 observations to Thermo Pac, LLC in Stone Mo'untain, Georgia (FEI 1031630) after an inspection that ran May 23 – Jun 3, 2011. The investigators were Arlyss M. Jones, Robert P. Neligan and Rory C. Burton. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 110.80 (processes and controls).

At a glance

Observations span 1 system, led by food cgmp / preventive controls.

Food CGMP / preventive controls2
Other6

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 108.25(c)(2)

    Failure to provide the FDA, before packing any new product, information on the scheduled processes for…

  2. 02
    21 CFR 108.35(c)(2)

    Failure: to provide FDA, before packing any new product, information as to the scheduled process for…

  3. 03
    21 CFR 114.80(a)(1)

    Acidified foods are not thermally processed to an extent that is sufficient to destroy the vegetative…

  4. 04
    21 CFR 110.80

    Failure to perform chemical testing where necessary to identify sanitation failures and possible food contamination. The…

4 more observations

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

Get the full 483

This inspection in context

The investigator

Arlyss M. Jones

1 document · 2011

Cites 110.80 (processes and controls) more than any other section. Most of their documents are for sites in Georgia.

The firm

Thermo Pac, LLC 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 108.25(c)(2)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Thermo Pac, LLC?

FDA listed 8 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 Thermo Pac, LLC?

Arlyss M. Jones, Robert P. Neligan and Rory C. Burton are named on this Form 483, for the inspection of May 23 – Jun 3, 2011. Each investigator has a profile showing what they cite most.

When was Thermo Pac, LLC inspected by FDA?

The inspection ran May 23 – Jun 3, 2011, and the Form 483 is dated June 3, 2011.

How do I get the full Form 483 for Thermo Pac, LLC?

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