Form 483

Total Nutrition Partners, LLC dba Total Nutrition Technology Form 483, 2017-09-21

FDA issued a Form 483 to Total Nutrition Partners, LLC dba Total Nutrition Technology on 2017-09-21 with 12 public-safe observations.

483· Form 483 issuedFoods & Cosmetics12 observations

Total Nutrition Partners, LLC dba Total Nutrition Technology · Leesburg, United States · Issued September 21, 2017

Overview

  • 12 public-safe observations are available for this inspection.
  • 6 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.

21 Sep 2017
21 CFR 111.135

Quality control operations - product complaints; investigate

Cited by Linda K Matheny

21 Sep 2017
21 CFR 111.135

Quality control operations - product complaints; investigate

Cited by Linda K Matheny

21 Sep 2017
21 CFR 111.16

Written procedures - cleaning

Cited by Linda K Matheny

21 Sep 2017
21 CFR 111.16

Written procedures - cleaning

Cited by Linda K Matheny

21 Sep 2017
21 CFR 111.260(c)

Batch record - date, time; maintenance

Cited by Linda K Matheny

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.135Cited across public-safe Form 483 observations2x
21 CFR 111.16Cited across public-safe Form 483 observations2x
21 CFR 111.260(c)Cited across public-safe Form 483 observations2x
21 CFR 111.410(b)Cited across public-safe Form 483 observations2x
21 CFR 111.73Cited across public-safe Form 483 observations2x
21 CFR 211.56(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 12 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