Atlas

Form 483

Wholistic Botanicals LLC Form 483, 2015-03-06

FDA issued a Form 483 to Wholistic Botanicals LLC on 2015-03-06 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Wholistic Botanicals LLC · Spanish Fork, United States · Issued March 6, 2015

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

6 Mar 2015
21 CFR 111.365(i)

Metal, foreign material

Cited by Andrea J Schmidt

6 Mar 2015
21 CFR 111.415(c)

Filling, assembling, packaging, labeling - sanitary handling

Cited by Andrea J Schmidt

Inspected site

WBWholistic Botanicals LLCSpanish Fork, United States

Inspection team

AJAndrea J Schmidt

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.365(i)Cited across public-safe Form 483 observations1x
21 CFR 111.415(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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