Form 483

Old Carolina Farm Form 483, 2010-03-26

FDA issued a Form 483 to Old Carolina Farm on 2010-03-26 with 3 public-safe observations.

483· Form 483 issued3 observations

Old Carolina Farm · Ijamsville, United States · Issued March 26, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 2 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.

26 Mar 2010
FDCA 402(a)(4)

Drug inventory

Cited by John Dan, William D Murray

26 Mar 2010
FDCA 402(a)(4)

Record keeping

Cited by John Dan, William D Murray

26 Mar 2010
FDCA 501(a)(5)

Expired drugs

Cited by John Dan, William D Murray

Inspected site

OCOld Carolina FarmIjamsville, 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
FDCA 501(a)(5)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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