Form 483

Dorina/So-Good, Inc. Form 483, 2009-10-07

FDA issued a Form 483 to Dorina/So-Good, Inc. on 2009-10-07 with 3 public-safe observations.

483· Form 483 issued3 observations

Dorina/So-Good, Inc. · Union, United States · Issued October 7, 2009

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

7 Oct 2009
21 CFR 123.6(c)(2)

Critical control points

Cited by William Nelson

7 Oct 2009
21 CFR 123.6(c)(3)

Critical limits

Cited by William Nelson

7 Oct 2009
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by William Nelson

Inspected site

DIDorina/So-Good, Inc.Union, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)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 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