Form 483

Leatherbrook Holsteins, LLC Form 483, 2022-06-10

FDA issued a Form 483 to Leatherbrook Holsteins, LLC on 2022-06-10 with 6 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds6 observations

Leatherbrook Holsteins, LLC · Americus, United States · Issued June 10, 2022

Overview

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

10 Jun 2022
21 CFR 530.11(d)

ELDU - producer causes Illegal drug residue

Cited by Kenny R Robinson, Anthony S Puckett

10 Jun 2022
21 CFR 530.41(a)

Drugs prohibited for extralabel use in food-producing animal(s)

Cited by Kenny R Robinson, Anthony S Puckett

10 Jun 2022
FDCA 402(a)(4)

Record keeping

Cited by Kenny R Robinson, Anthony S Puckett

10 Jun 2022
FDCA 402(a)(4)

Records review prior to shipment for slaughter

Cited by Kenny R Robinson, Anthony S Puckett

10 Jun 2022
FDCA 402(a)(4)

Record keeping

Cited by Kenny R Robinson, Anthony S Puckett

Inspected site

LHLeatherbrook Holsteins, LLCAmericus, 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 observations4x
21 CFR 530.11(d)Cited across public-safe Form 483 observations1x
21 CFR 530.41(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 6 observations

The source PDF, 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