Form 483

OM Holdings, Ltd. d.b.a. Organic Holding Company Form 483, 2008-10-28

FDA issued a Form 483 to OM Holdings, Ltd. d.b.a. Organic Holding Company on 2008-10-28 with 4 public-safe observations.

483· Form 483 issued4 observations

OM Holdings, Ltd. d.b.a. Organic Holding Company · Washington, United States · Issued October 28, 2008

Overview

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

28 Oct 2008
21 CFR 123.6(a)

Hazard analysis

Cited by John Dan

28 Oct 2008
21 CFR 123.6(b)

No HACCP plan

Cited by John Dan

28 Oct 2008
21 CFR 123.10

HACCP training or qualification

Cited by John Dan

28 Oct 2008
21 CFR 123.11(b)

Sanitation monitoring

Cited by John Dan

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.10Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(a)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)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