Atlas

Form 483

Nature's Formulary, LLC Form 483, 2019-03-18

FDA issued a Form 483 to Nature's Formulary, LLC on 2019-03-18 with 16 public-safe observations.

483· Form 483 issuedFoods & Cosmetics16 observations

Nature's Formulary, LLC · Ballston Spa, United States · Issued March 18, 2019

Overview

  • 16 public-safe observations are available for this inspection.
  • 4 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.

18 Mar 2019
21 CFR 111.103

Written procedures - quality control operations

Cited by Melissa A Henaghan

18 Mar 2019
21 CFR 111.103

Written procedures - quality control operations

Cited by Melissa A Henaghan

18 Mar 2019
21 CFR 111.16

Written procedures - cleaning

Cited by Melissa A Henaghan

18 Mar 2019
21 CFR 111.16

Written procedures - cleaning

Cited by Melissa A Henaghan

18 Mar 2019
21 CFR 111.453

Written procedures - holding

Cited by Melissa A Henaghan

Inspected site

NFNature's Formulary, LLCBallston Spa, United States

Inspection team

MAMelissa A Henaghan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.453Cited across public-safe Form 483 observations5x
21 CFR 111.70(e)Cited across public-safe Form 483 observations5x
21 CFR 111.103Cited across public-safe Form 483 observations3x
21 CFR 111.16Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 16 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