Form 483

Detox Transforms Form 483, 2019-05-23

FDA issued a Form 483 to Detox Transforms on 2019-05-23 with 24 public-safe observations.

483· Form 483 issuedFoods & Cosmetics24 observations

Detox Transforms · Angier, United States · Issued May 23, 2019

Overview

  • 24 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.

23 May 2019
21 CFR 111.103

Written procedures - quality control operations

Cited by Radona R Boutte

23 May 2019
21 CFR 111.103

Written procedures - quality control operations

Cited by Radona R Boutte

23 May 2019
21 CFR 111.13(b)

Supervisor - education, training

Cited by Radona R Boutte

23 May 2019
21 CFR 111.13(b)

Supervisor - education, training

Cited by Radona R Boutte

23 May 2019
21 CFR 111.553

Written procedures - product complaint

Cited by Radona R Boutte

Inspected site

DTDetox TransformsAngier, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.553Cited across public-safe Form 483 observations6x
21 CFR 111.75(c)Cited across public-safe Form 483 observations6x
21 CFR 111.83(a)Cited across public-safe Form 483 observations6x
21 CFR 111.103Cited across public-safe Form 483 observations2x
21 CFR 111.13(b)Cited across public-safe Form 483 observations2x
21 CFR 111.570(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 24 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