Form 483

New Spirit Naturals Inc. Form 483, 2010-09-07

FDA issued a Form 483 to New Spirit Naturals Inc. on 2010-09-07 with 10 public-safe observations.

483· Form 483 issued10 observations

New Spirit Naturals Inc. · San Dimas, United States · Issued September 7, 2010

Overview

  • 10 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.

7 Sep 2010
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Diane C Van Leeuwen

7 Sep 2010
21 CFR 211.80(d)

Status of Each Lot Identified

Cited by Diane C Van Leeuwen

7 Sep 2010
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Diane C Van Leeuwen

7 Sep 2010
21 CFR 211.142

Written warehousing procedures established/followed

Cited by Diane C Van Leeuwen

7 Sep 2010
21 CFR 211.142(a)

Quarantine - actual practice

Cited by Diane C Van Leeuwen

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 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.142Cited across public-safe Form 483 observations1x
21 CFR 211.142(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(11)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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