Atlas

Form 483

Shaman Botanicals, LLC Form 483, 2026-04-09

FDA issued a Form 483 to Shaman Botanicals, LLC on 2026-04-09 with 15 public-safe observations.

483· Form 483 issuedFoods & Cosmetics15 observations

Shaman Botanicals, LLC · North Kansas City, United States · Issued April 9, 2026

Overview

  • 15 public-safe observations are available for this inspection.
  • 15 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

9 Apr 2026
21 CFR 111.103

Written procedures - follow; quality control operations

Cited by Alicia Frees, Lionell L Thomas

9 Apr 2026
21 CFR 111.120(e)

Quality control operations - quarantine

Cited by Alicia Frees, Lionell L Thomas

9 Apr 2026
21 CFR 111.155(d)(1)

Components - identify lot received

Cited by Alicia Frees, Lionell L Thomas

9 Apr 2026
21 CFR 111.15(b)

Physical plant - clean and sanitary

Cited by Alicia Frees, Lionell L Thomas

9 Apr 2026
21 CFR 111.205(a)

Master manufacturing record - prepared

Cited by Alicia Frees, Lionell L Thomas

Inspected site

SBShaman Botanicals, LLCNorth Kansas City, United States

Inspection team

AFAlicia Frees
LLLionell L Thomas

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.120(e)Cited across public-safe Form 483 observations1x
21 CFR 111.15(b)Cited across public-safe Form 483 observations1x
21 CFR 111.155(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.205(a)Cited across public-safe Form 483 observations1x
21 CFR 111.23(b)Cited across public-safe Form 483 observations1x
21 CFR 111.260Cited across public-safe Form 483 observations1x
21 CFR 111.27(b)Cited across public-safe Form 483 observations1x
21 CFR 111.303Cited across public-safe Form 483 observations1x
21 CFR 111.35(b)Cited across public-safe Form 483 observations1x
21 CFR 111.55Cited across public-safe Form 483 observations1x
21 CFR 111.605(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 15 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