Atlas

Form 483

Threshold Enterprises, Ltd. Form 483, 2013-09-03

FDA issued a Form 483 to Threshold Enterprises, Ltd. on 2013-09-03 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Threshold Enterprises, Ltd. · Scotts Valley, United States · Issued September 3, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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 Sep 2013
21 CFR 111.20(c)(2)

Physical plant - material review and disposition

Cited by Jennifer L Johnson

3 Sep 2013
21 CFR 111.303

Written procedures - laboratory operations

Cited by Jennifer L Johnson

Inspected site

TEThreshold Enterprises, Ltd.Scotts Valley, United States

Inspection team

JLJennifer L Johnson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.20(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.303Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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