Atlas

Form 483

GATE GOURMET, INC. Form 483, 2012-09-07

FDA issued a Form 483 to GATE GOURMET, INC. on 2012-09-07 with 2 public-safe observations.

483· Form 483 issued2 observations

GATE GOURMET, INC. · Tampa, United States · Issued September 7, 2012

Overview

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

Inspectional observations

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

7 Sep 2012
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Melinda B Lewis, Rodney W Lenger

7 Sep 2012
21 CFR 1250.32(a)

Contamination

Cited by Melinda B Lewis, Rodney W Lenger

Inspected site

GGGATE GOURMET, INC.Tampa, United States

Inspection team

MBMelinda B Lewis
RWRodney W Lenger

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 1250.32(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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