Atlas

Form 483

Rainville Dairy, LLC Form 483, 2011-08-12

FDA issued a Form 483 to Rainville Dairy, LLC on 2011-08-12 with 5 public-safe observations.

483· Form 483 issued5 observations

Rainville Dairy, LLC · Highgate Center, United States · Issued August 12, 2011

Overview

  • 5 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.

12 Aug 2011
21 CFR 530.11(d)

Tissue residue

Cited by Isaac K Carney, David S Firley

12 Aug 2011
FDCA 402(a)(4)

Drug inventory

Cited by Isaac K Carney, David S Firley

12 Aug 2011
FDCA 402(a)(4)

Record keeping

Cited by Isaac K Carney, David S Firley

12 Aug 2011
FDCA 501(a)(5)

Expired drugs

Cited by Isaac K Carney, David S Firley

12 Aug 2011
FDCA 501(a)(5)

Extra label use w/o veterinary client-patient relationship

Cited by Isaac K Carney, David S Firley

Inspected site

RDRainville Dairy, LLCHighgate Center, United States

Inspection team

IKIsaac K Carney
DSDavid S Firley

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 402(a)(4)Cited across public-safe Form 483 observations2x
FDCA 501(a)(5)Cited across public-safe Form 483 observations2x
21 CFR 530.11(d)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