Form 483

Blue Diamond Growers Form 483, 2010-02-12

FDA issued a Form 483 to Blue Diamond Growers on 2010-02-12 with 5 public-safe observations.

483· Form 483 issued5 observations

Blue Diamond Growers · Sacramento, United States · Issued February 12, 2010

Overview

  • 5 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 5 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

12 Feb 2010
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by William V Millar, Jennifer H Rhyu, Karen D Phung, Mabel M Lee, Brett W Podoski

12 Feb 2010
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by William V Millar, Jennifer H Rhyu, Karen D Phung, Mabel M Lee, Brett W Podoski

12 Feb 2010
21 CFR 110.35(d)(5)

Safe and adequate for use

Cited by William V Millar, Jennifer H Rhyu, Karen D Phung, Mabel M Lee, Brett W Podoski

12 Feb 2010
21 CFR 110.35(d)(5)

Shown to be effective

Cited by William V Millar, Jennifer H Rhyu, Karen D Phung, Mabel M Lee, Brett W Podoski

12 Feb 2010
21 CFR 110.80(b)(13)

Filling, assembling, packing controls

Cited by William V Millar, Jennifer H Rhyu, Karen D Phung, Mabel M Lee, Brett W Podoski

Inspected site

BDBlue Diamond GrowersSacramento, United States

Inspection team

JHJennifer H Rhyu
KDKaren D Phung

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(13)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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