Atlas

Form 483

Evol Nutrition Associates, Inc. Form 483, 2022-03-07

FDA issued a Form 483 to Evol Nutrition Associates, Inc. on 2022-03-07 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Evol Nutrition Associates, Inc. · Marietta, United States · Issued March 7, 2022

Overview

  • 3 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.

7 Mar 2022
21 CFR 111.103

Written procedures - quality control operations

Cited by Joseph F Owens

7 Mar 2022
21 CFR 111.70(e)

Specifications - identity, purity, strength, composition

Cited by Joseph F Owens

7 Mar 2022
21 CFR 111.75(c)

Specifications met - verify; finished batch

Cited by Joseph F Owens

Inspected site

ENEvol Nutrition Associates, Inc.Marietta, United States

Inspection team

JFJoseph F Owens

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x
21 CFR 111.75(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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