Form 483

San Diego Soy Dairy, Inc. Form 483, 2011-06-03

FDA issued a Form 483 to San Diego Soy Dairy, Inc. on 2011-06-03 with 17 public-safe observations.

483· Form 483 issued17 observations

San Diego Soy Dairy, Inc. · El Cajon, United States · Issued June 3, 2011

Overview

  • 17 public-safe observations are available for this inspection.
  • 15 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.

3 Jun 2011
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Kevin T Gerrity

3 Jun 2011
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Kevin T Gerrity

3 Jun 2011
21 CFR 110.10(b)(4)

Hand jewelry - remove/cover

Cited by Kevin T Gerrity

3 Jun 2011
21 CFR 110.20(a)(1)

Harborage areas

Cited by Kevin T Gerrity

3 Jun 2011
21 CFR 110.20(b)(7)

Screening

Cited by Kevin T Gerrity

Inspected site

SDSan Diego Soy Dairy, Inc.El Cajon, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(c)Cited across public-safe Form 483 observations2x
21 CFR 110.40(a)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(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(d)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 17 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