Form 483

Healthy Delites, Inc. Form 483, 2011-12-29

FDA issued a Form 483 to Healthy Delites, Inc. on 2011-12-29 with 4 public-safe observations.

483· Form 483 issued4 observations

Healthy Delites, Inc. · Brooklyn, United States · Issued December 29, 2011

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.

29 Dec 2011
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Sarah A Wangseng, Tara K Normandin

29 Dec 2011
21 CFR 110.20(b)(7)

Screening

Cited by Sarah A Wangseng, Tara K Normandin

29 Dec 2011
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Sarah A Wangseng, Tara K Normandin

29 Dec 2011
21 CFR 110.37(e)(3)

Hand drying

Cited by Sarah A Wangseng, Tara K Normandin

Inspected site

HDHealthy Delites, Inc.Brooklyn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(3)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