Form 483

Choice All Natural Inc D Form 483, 2024-02-26

FDA issued a Form 483 to Choice All Natural Inc D on 2024-02-26 with 13 public-safe observations.

483· Form 483 issuedHuman Drugs13 observations

Choice All Natural Inc D · Apex, United States · Issued February 26, 2024

Overview

  • 13 public-safe observations are available for this inspection.
  • 13 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.

26 Feb 2024
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Daveta L Bailey

26 Feb 2024
21 CFR 211.110(c)

In-process materials characteristics testing

Cited by Daveta L Bailey

26 Feb 2024
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Daveta L Bailey

26 Feb 2024
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Daveta L Bailey

26 Feb 2024
21 CFR 211.165(a)

Testing and release for distribution

Cited by Daveta L Bailey

Inspected site

CAChoice All Natural Inc DApex, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(c)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 13 observations

The source PDF, 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