Atlas

Form 483

Natural Option USA Corp Form 483, 2016-09-21

FDA issued a Form 483 to Natural Option USA Corp on 2016-09-21 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Natural Option USA Corp · Pinecrest, United States · Issued September 21, 2016

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

21 Sep 2016
21 CFR 111.103

Written procedures - quality control operations

Cited by Sharon Giamberini

21 Sep 2016
21 CFR 111.453

Written procedures - holding

Cited by Sharon Giamberini

21 Sep 2016
21 CFR 111.503

Written procedures - returned dietary supplement

Cited by Sharon Giamberini

21 Sep 2016
21 CFR 111.55

Production, process controls - implement

Cited by Sharon Giamberini

21 Sep 2016
21 CFR 111.553

Written procedures - product complaint

Cited by Sharon Giamberini

Inspected site

NONatural Option USA CorpPinecrest, United States

Inspection team

SGSharon Giamberini

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.453Cited across public-safe Form 483 observations1x
21 CFR 111.503Cited across public-safe Form 483 observations1x
21 CFR 111.55Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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