Form 483

Fervalue USA, Inc. (Augusta Bakery) Form 483, 2011-10-28

FDA issued a Form 483 to Fervalue USA, Inc. (Augusta Bakery) on 2011-10-28 with 5 public-safe observations.

483· Form 483 issued5 observations

Fervalue USA, Inc. (Augusta Bakery) · Augusta, United States · Issued October 28, 2011

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

28 Oct 2011
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Robert P Neligan, Christina H Owens, Chauncey A Stephens, Robert W Turner, William K Ducloux

28 Oct 2011
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Robert P Neligan, Christina H Owens, Chauncey A Stephens, Robert W Turner, William K Ducloux

28 Oct 2011
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Robert P Neligan, Christina H Owens, Chauncey A Stephens, Robert W Turner, William K Ducloux

28 Oct 2011
21 CFR 110.80(b)(7)

Equipment, containers, utensils

Cited by Robert P Neligan, Christina H Owens, Chauncey A Stephens, Robert W Turner, William K Ducloux

28 Oct 2011
21 CFR 110.93

Storage/transportation of finished goods (deterioration)

Cited by Robert P Neligan, Christina H Owens, Chauncey A Stephens, Robert W Turner, William K Ducloux

Inspected site

FUFervalue USA, Inc. (Augusta Bakery)Augusta, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 observations

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