Form 483

Providence Dairy, LLC Form 483, 2009-09-28

FDA issued a Form 483 to Providence Dairy, LLC on 2009-09-28 with 5 public-safe observations.

483· Form 483 issued5 observations

Providence Dairy, LLC · Twelve Mile, United States · Issued September 28, 2009

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.

28 Sep 2009
21 CFR 530.20(a)(2)(iv)

Tissue residue

Cited by Bernard P Heidt

28 Sep 2009
FDCA 402(a)(4)

Drug inventory

Cited by Bernard P Heidt

28 Sep 2009
FDCA 402(a)(4)

Record keeping

Cited by Bernard P Heidt

28 Sep 2009
FDCA 402(a)(4)

System for administration of drugs

Cited by Bernard P Heidt

28 Sep 2009
FDCA 501(a)(5)

Conditions of use

Cited by Bernard P Heidt

Inspected site

PDProvidence Dairy, LLCTwelve Mile, 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 530.20(a)(2)(iv)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