Form 483

Ultimate Living International Inc Form 483, 2021-05-21

FDA issued a Form 483 to Ultimate Living International Inc on 2021-05-21 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Ultimate Living International Inc · Dallas, United States · Issued May 21, 2021

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

21 May 2021
21 CFR 111.103

Written procedures - quality control operations

Cited by Denise Connelly

21 May 2021
21 CFR 111.73

Specifications met - identity, purity, strength, composition

Cited by Denise Connelly

21 May 2021
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by Denise Connelly

21 May 2021
21 CFR 111.75(a)(2)(ii)(D)

Re-confirm certificate of analysis

Cited by Denise Connelly

21 May 2021
21 CFR 111.75(h)(2)

Tests, examinations - scientifically valid

Cited by Denise Connelly

Inspected site

ULUltimate Living International IncDallas, 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 observations1x
21 CFR 111.73Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(D)Cited across public-safe Form 483 observations1x
21 CFR 111.75(h)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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