Form 483

New Spirit Naturals Inc. Form 483, 2021-08-24

FDA issued a Form 483 to New Spirit Naturals Inc. on 2021-08-24 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

New Spirit Naturals Inc. · San Dimas, United States · Issued August 24, 2021

Overview

  • 10 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.

24 Aug 2021
21 CFR 111.255(b)

Batch record - complete

Cited by Celena Ngo

24 Aug 2021
21 CFR 111.255(b)

Batch record - complete

Cited by Celena Ngo

24 Aug 2021
21 CFR 111.70(b)(3)

Specifications - contamination limits

Cited by Celena Ngo

24 Aug 2021
21 CFR 111.70(b)(3)

Specifications - contamination limits

Cited by Celena Ngo

24 Aug 2021
21 CFR 111.70(e)

Specifications - identity, purity, strength, composition

Cited by Celena Ngo

Inspected site

NSNew Spirit Naturals Inc.San Dimas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.255(b)Cited across public-safe Form 483 observations2x
21 CFR 111.70(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 111.70(e)Cited across public-safe Form 483 observations2x
21 CFR 120.24(a)Cited across public-safe Form 483 observations2x
21 CFR 120.7(a)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 10 observations

The source PDF, 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