Form 483

Gourmail, Inc. Form 483, 2010-06-23

FDA issued a Form 483 to Gourmail, Inc. on 2010-06-23 with 4 public-safe observations.

483· Form 483 issued4 observations

Gourmail, Inc. · Sharon Hill, United States · Issued June 23, 2010

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

23 Jun 2010
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Brian D Young, Judith A Paterson

23 Jun 2010
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Brian D Young, Judith A Paterson

23 Jun 2010
21 CFR 110.80(b)(3)

Holding foods - refrigerate/freeze/heat

Cited by Brian D Young, Judith A Paterson

23 Jun 2010
21 CFR 1250.30(d)

Plumbing design, installation, maintenance

Cited by Brian D Young, Judith A Paterson

Inspected site

GIGourmail, Inc.Sharon Hill, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 1250.30(d)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