Atlas

Form 483

K'an Herb Company, Inc. Form 483, 2019-05-24

FDA issued a Form 483 to K'an Herb Company, Inc. on 2019-05-24 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

K'an Herb Company, Inc. · Santa Cruz, United States · Issued May 24, 2019

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.

24 May 2019
21 CFR 111.255(c)

Batch record - each step

Cited by Lourdes Andujar

24 May 2019
21 CFR 111.260(l)(1)

Batch record - quality control review; production

Cited by Lourdes Andujar

Inspected site

KHK'an Herb Company, Inc.Santa Cruz, United States

Inspection team

LALourdes Andujar

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.255(c)Cited across public-safe Form 483 observations1x
21 CFR 111.260(l)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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