Form 483

Dutra Farms Inc Form 483, 2010-08-03

FDA issued a Form 483 to Dutra Farms Inc on 2010-08-03 with 4 public-safe observations.

483· Form 483 issued4 observations

Dutra Farms Inc · Manteca, United States · Issued August 3, 2010

Overview

  • 4 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.

3 Aug 2010
21 CFR 530.11(d)

Tissue residue

Cited by Victoria D Taylor

3 Aug 2010
FDCA 402(a)(4)

Drug inventory

Cited by Victoria D Taylor

3 Aug 2010
FDCA 402(a)(4)

Record keeping

Cited by Victoria D Taylor

3 Aug 2010
FDCA 501(a)(5)

Expired drugs

Cited by Victoria D Taylor

Inspected site

DFDutra Farms IncManteca, 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 observations2x
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 4 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