Form 483

Mancebo Holsteins Dairy #1 Form 483, 2010-09-07

FDA issued a Form 483 to Mancebo Holsteins Dairy #1 on 2010-09-07 with 5 public-safe observations.

483· Form 483 issued5 observations

Mancebo Holsteins Dairy #1 · Tulare, United States · Issued September 7, 2010

Overview

  • 5 public-safe observations are available for this inspection.
  • 3 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.

7 Sep 2010
21 CFR 530.11(d)

Tissue residue

Cited by Gulshan R Anand

7 Sep 2010
FDCA 402(a)(4)

Drug inventory

Cited by Gulshan R Anand

7 Sep 2010
FDCA 402(a)(4)

Record keeping

Cited by Gulshan R Anand

7 Sep 2010
FDCA 402(a)(4)

Records review prior to slaughter

Cited by Gulshan R Anand

7 Sep 2010
FDCA 501(a)(5)

Extra label use w/o veterinary client-patient relationship

Cited by Gulshan R Anand

Inspected site

MHMancebo Holsteins Dairy #1Tulare, 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 observations3x
21 CFR 530.11(d)Cited across public-safe Form 483 observations1x
FDCA 501(a)(5)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