Form 483

Souza Dairy, Alvin Form 483, 2012-05-23

FDA issued a Form 483 to Souza Dairy, Alvin on 2012-05-23 with 5 public-safe observations.

483· Form 483 issued5 observations

Souza Dairy, Alvin · Tulare, United States · Issued May 23, 2012

Overview

  • 5 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.

23 May 2012
21 CFR 530.11(a)

Route of administration

Cited by Thomas W Gordon

23 May 2012
21 CFR 530.11(d)

Tissue residue

Cited by Thomas W Gordon

23 May 2012
21 CFR 530.41(a)

Drugs prohibited for extralabel use in food producing animal

Cited by Thomas W Gordon

23 May 2012
FDCA 402(a)(4)

Drug inventory

Cited by Thomas W Gordon

23 May 2012
FDCA 402(a)(4)

Record keeping

Cited by Thomas W Gordon

Inspected site

SDSouza Dairy, AlvinTulare, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 402(a)(4)Cited across public-safe Form 483 observations2x
21 CFR 530.11(a)Cited across public-safe Form 483 observations1x
21 CFR 530.11(d)Cited across public-safe Form 483 observations1x
21 CFR 530.41(a)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