Form 483

The Other Brother Darryl's, Inc. Form 483, 2012-09-25

FDA issued a Form 483 to The Other Brother Darryl's, Inc. on 2012-09-25 with 2 public-safe observations.

483· Form 483 issued2 observations

The Other Brother Darryl's, Inc. · Otis, United States · Issued September 25, 2012

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

25 Sep 2012
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Pamela L Ogonowski

25 Sep 2012
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by Pamela L Ogonowski

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)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