Form 483

OM Holdings, Ltd. d.b.a. Organic Holding Company Form 483, 2009-11-09

FDA issued a Form 483 to OM Holdings, Ltd. d.b.a. Organic Holding Company on 2009-11-09 with 6 public-safe observations.

483· Form 483 issued6 observations

OM Holdings, Ltd. d.b.a. Organic Holding Company · Washington, United States · Issued November 9, 2009

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

9 Nov 2009
21 CFR 123.6(b)

HACCP plan implementation

Cited by Hector J Colon-Torres, Dawn M Collins

9 Nov 2009
21 CFR 123.6(d)

Signed and dated

Cited by Hector J Colon-Torres, Dawn M Collins

9 Nov 2009
21 CFR 123.10

HACCP training or qualification

Cited by Hector J Colon-Torres, Dawn M Collins

9 Nov 2009
21 CFR 123.11(a)

SSOP(S)

Cited by Hector J Colon-Torres, Dawn M Collins

9 Nov 2009
21 CFR 123.11(b)

Sanitation monitoring

Cited by Hector J Colon-Torres, Dawn M Collins

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(a)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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