Form 483

Wholistic Botanicals LLC Form 483, 2018-03-23

FDA issued a Form 483 to Wholistic Botanicals LLC on 2018-03-23 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Wholistic Botanicals LLC · Spanish Fork, United States · Issued March 23, 2018

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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 Mar 2018
21 CFR 111.255(b)

Batch record - complete

Cited by Lavender M Huskey

23 Mar 2018
21 CFR 111.70(b)(1)

Specifications - component identity

Cited by Lavender M Huskey

23 Mar 2018
21 CFR 111.70(b)(2)

Specifications-component purity, strength, composition

Cited by Lavender M Huskey

Inspected site

WBWholistic Botanicals LLCSpanish Fork, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.255(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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