Atlas

Form 483

Gourmail, Inc. Form 483, 2014-05-01

FDA issued a Form 483 to Gourmail, Inc. on 2014-05-01 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Gourmail, Inc. · Sharon Hill, United States · Issued May 1, 2014

Overview

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

Inspectional observations

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

1 May 2014
21 CFR 110.10(c)

Training of handlers and supervisors

Cited by Sean D Duke, Deborah H Cozzone, Erika M Wilkerson, Deborah G Haney Cozzone

1 May 2014
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Sean D Duke, Deborah H Cozzone, Erika M Wilkerson, Deborah G Haney Cozzone

1 May 2014
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Sean D Duke, Deborah H Cozzone, Erika M Wilkerson, Deborah G Haney Cozzone

Inspected site

GIGourmail, Inc.Sharon Hill, United States

Inspection team

SDSean D Duke
DHDeborah H Cozzone
EMErika M Wilkerson
DGDeborah G Haney Cozzone

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 110.10(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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