Form 483

T.G. Lee Dairy Form 483, 2012-04-30

FDA issued a Form 483 to T.G. Lee Dairy on 2012-04-30 with 4 public-safe observations.

483· Form 483 issued4 observations

T.G. Lee Dairy · Orange City, United States · Issued April 30, 2012

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.

30 Apr 2012
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Ashley Segura

30 Apr 2012
21 CFR 120.6(b)

Sanitation monitoring

Cited by Ashley Segura

30 Apr 2012
21 CFR 120.11(a)(1)(iv)

Records - not signed and dated by qualified individual

Cited by Ashley Segura

30 Apr 2012
21 CFR 120.11(a)(1)(iv)

Verification - CCP, CA record review

Cited by Ashley Segura

Inspected site

TLT.G. Lee DairyOrange City, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.11(a)(1)(iv)Cited across public-safe Form 483 observations2x
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)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