Form 483

North River Dairy Form 483, 2018-08-27

FDA issued a Form 483 to North River Dairy on 2018-08-27 with 4 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds4 observations

North River Dairy · Mount Crawford, United States · Issued August 27, 2018

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

27 Aug 2018
21 CFR 530.11(d)

Tissue residue

Cited by Andrew J Howard, Margaret Torres-Vazquez

27 Aug 2018
21 CFR 530.41(a)

Drugs prohibited for extralabel use in food producing animal

Cited by Andrew J Howard, Margaret Torres-Vazquez

27 Aug 2018
FDCA 402(a)(4)

Record keeping

Cited by Andrew J Howard, Margaret Torres-Vazquez

27 Aug 2018
FDCA 501(a)(5)

Extra label use w/o veterinary client-patient relationship

Cited by Andrew J Howard, Margaret Torres-Vazquez

Inspected site

NRNorth River DairyMount Crawford, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

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

The full inspection record, as Atlas holds it, 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