Form 483

GATE GOURMET, INC. Form 483, 2010-01-13

FDA issued a Form 483 to GATE GOURMET, INC. on 2010-01-13 with 4 public-safe observations.

483· Form 483 issued4 observations

GATE GOURMET, INC. · Tampa, United States · Issued January 13, 2010

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

13 Jan 2010
21 CFR 110.35(a)

Buildings/sanitary

Cited by Diana L Kelsch

13 Jan 2010
21 CFR 110.35(b)(2)

Storage requirements

Cited by Diana L Kelsch

13 Jan 2010
21 CFR 110.35(d)(4)

Single-service articles

Cited by Diana L Kelsch

13 Jan 2010
21 CFR 1250.32(a)

Contamination

Cited by Diana L Kelsch

Inspected site

GGGATE GOURMET, INC.Tampa, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(4)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 4 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