Form 483

Terhune Orchards, LLC Form 483, 2019-11-22

FDA issued a Form 483 to Terhune Orchards, LLC on 2019-11-22 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Terhune Orchards, LLC · Princeton, United States · Issued November 22, 2019

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

22 Nov 2019
21 CFR 120.10(a)

Corrective action - predetermined plan

Cited by Jennifer A Bazergui, Kyle D Covill

22 Nov 2019
21 CFR 120.11(a)(1)

Verification activities - minimum

Cited by Jennifer A Bazergui, Kyle D Covill

22 Nov 2019
21 CFR 120.6(b)

Sanitation monitoring

Cited by Jennifer A Bazergui, Kyle D Covill

22 Nov 2019
21 CFR 120.8(b)(4)

HACCP plan - monitoring procedures not adequate

Cited by Jennifer A Bazergui, Kyle D Covill

Inspected site

TOTerhune Orchards, LLCPrinceton, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.10(a)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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