Form 483

Golden Gate Soy Products, Inc. Form 483, 2010-07-29

FDA issued a Form 483 to Golden Gate Soy Products, Inc. on 2010-07-29 with 14 public-safe observations.

483· Form 483 issued14 observations

Golden Gate Soy Products, Inc. · San Francisco, United States · Issued July 29, 2010

Overview

  • 14 public-safe observations are available for this inspection.
  • 13 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.

29 Jul 2010
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Jennifer H Rhyu, Frank P Bianco

29 Jul 2010
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Jennifer H Rhyu, Frank P Bianco

29 Jul 2010
21 CFR 110.20(a)(4)

Waste disposal

Cited by Jennifer H Rhyu, Frank P Bianco

29 Jul 2010
21 CFR 110.20(b)(1)

Sufficient space

Cited by Jennifer H Rhyu, Frank P Bianco

29 Jul 2010
21 CFR 110.20(b)(7)

Screening

Cited by Jennifer H Rhyu, Frank P Bianco

Inspected site

GGGolden Gate Soy Products, Inc.San Francisco, United States

Inspection team

JHJennifer H Rhyu

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.40(e)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 14 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