Form 483

Thermo Pac LLC Form 483, 2011-06-03

FDA issued a Form 483 to Thermo Pac LLC on 2011-06-03 with 8 public-safe observations.

483· Form 483 issued8 observations

Thermo Pac LLC · Stone Mountain, United States · Issued June 3, 2011

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 structured CFR citations are represented.
  • 5 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

3 Jun 2011
21 CFR 108.25(c)(2)

Process filing

Cited by Arlyss M Jones, Robert P Neligan, Theresa L Stewart, Nelson A Rodriguez, Rory C Burton

3 Jun 2011
21 CFR 108.35(c)(2)

Process filing

Cited by Arlyss M Jones, Robert P Neligan, Theresa L Stewart, Nelson A Rodriguez, Rory C Burton

3 Jun 2011
21 CFR 110.80

Testing

Cited by Arlyss M Jones, Robert P Neligan, Theresa L Stewart, Nelson A Rodriguez, Rory C Burton

3 Jun 2011
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Arlyss M Jones, Robert P Neligan, Theresa L Stewart, Nelson A Rodriguez, Rory C Burton

3 Jun 2011
21 CFR 113.10

Supervisors

Cited by Arlyss M Jones, Robert P Neligan, Theresa L Stewart, Nelson A Rodriguez, Rory C Burton

Inspected site

TPThermo Pac LLCStone Mountain, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 108.35(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 113.10Cited across public-safe Form 483 observations1x
21 CFR 114.10Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 114.89Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 8 observations

The source PDF and every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere