Atlas

Form 483

Innovita, LLC Form 483, 2018-05-09

FDA issued a Form 483 to Innovita, LLC on 2018-05-09 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Innovita, LLC · Ogden, United States · Issued May 9, 2018

Overview

  • 4 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.

9 May 2018
21 CFR 111.103

Written procedures - quality control operations

Cited by Courtney R Ingalsbe

9 May 2018
21 CFR 111.103

Written procedures - quality control operations

Cited by Courtney R Ingalsbe

9 May 2018
21 CFR 111.610(a)

Records - available; FDA

Cited by Courtney R Ingalsbe

9 May 2018
21 CFR 111.610(a)

Records - available; FDA

Cited by Courtney R Ingalsbe

Inspected site

ILInnovita, LLCOgden, United States

Inspection team

CRCourtney R Ingalsbe

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations2x
21 CFR 111.610(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 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