Form 483

Diamond Nutriceutical, Inc. Form 483, 2021-05-10

FDA issued a Form 483 to Diamond Nutriceutical, Inc. on 2021-05-10 with 20 public-safe observations.

483· Form 483 issuedFoods & Cosmetics20 observations

Diamond Nutriceutical, Inc. · Pomona, United States · Issued May 10, 2021

Overview

  • 20 public-safe observations are available for this inspection.
  • 10 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 May 2021
21 CFR 111.103

Written procedures - quality control operations

Cited by Joseph C Yen

10 May 2021
21 CFR 111.103

Written procedures - quality control operations

Cited by Joseph C Yen

10 May 2021
21 CFR 111.105

Ensure quality; package, labeled, master record

Cited by Joseph C Yen

10 May 2021
21 CFR 111.105

Ensure quality; package, labeled, master record

Cited by Joseph C Yen

10 May 2021
21 CFR 111.140(a)

Records - quality control operations: 1 year, 2 years

Cited by Joseph C Yen

Inspected site

DNDiamond Nutriceutical, Inc.Pomona, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.103Cited across public-safe Form 483 observations2x
21 CFR 111.105Cited across public-safe Form 483 observations2x
21 CFR 111.140(a)Cited across public-safe Form 483 observations2x
21 CFR 111.205(a)Cited across public-safe Form 483 observations2x
21 CFR 111.403Cited across public-safe Form 483 observations2x
21 CFR 111.503Cited across public-safe Form 483 observations2x
21 CFR 111.553Cited across public-safe Form 483 observations2x
21 CFR 111.70(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 111.70(e)Cited across public-safe Form 483 observations2x
21 CFR 111.70(g)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 20 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