Form 483

JT Naturals, LLC. Form 483, 2013-07-11

FDA issued a Form 483 to JT Naturals, LLC. on 2013-07-11 with 9 public-safe observations.

483· Form 483 issuedFoods & Cosmetics9 observations

JT Naturals, LLC. · Joplin, United States · Issued July 11, 2013

Overview

  • 9 public-safe observations are available for this inspection.
  • 9 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.

11 Jul 2013
21 CFR 111.70(b)(2)

Specifications-component purity, strength, composition

Cited by Janete A Oliveira

11 Jul 2013
21 CFR 111.75(a)(1)(i)

Component - verify identity, dietary ingredient

Cited by Janete A Oliveira

11 Jul 2013
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by Janete A Oliveira

11 Jul 2013
21 CFR 111.75(c)

Specifications met - verify; finished batch

Cited by Janete A Oliveira

11 Jul 2013
21 CFR 111.205(b)(1)

Master manufacturing record - specifications; quality

Cited by Janete A Oliveira

Inspected site

JNJT Naturals, LLC.Joplin, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.205(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.210(h)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.260(c)Cited across public-safe Form 483 observations1x
21 CFR 111.260(d)Cited across public-safe Form 483 observations1x
21 CFR 111.260(k)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations1x
21 CFR 111.75(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 9 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