Atlas

Form 483

Natural Option USA Corp Form 483, 2019-09-10

FDA issued a Form 483 to Natural Option USA Corp on 2019-09-10 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Natural Option USA Corp · Pinecrest, United States · Issued September 10, 2019

Overview

  • 4 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.

10 Sep 2019
21 CFR 111.103

Written procedures - quality control operations

Cited by John J Bernal

10 Sep 2019
21 CFR 111.535(b)(2)

Records - ret'nd dietary supplement: material review, dispos

Cited by John J Bernal

10 Sep 2019
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by John J Bernal

10 Sep 2019
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by John J Bernal

Inspected site

NONatural Option USA CorpPinecrest, United States

Inspection team

JJJohn J Bernal

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations2x
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.535(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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