Atlas

Form 483

Natren Inc. Form 483, 2011-12-22

FDA issued a Form 483 to Natren Inc. on 2011-12-22 with 5 public-safe observations.

483· Form 483 issued5 observations

Natren Inc. · Thousand Oaks, United States · Issued December 22, 2011

Overview

  • 5 public-safe observations are available for this inspection.
  • 3 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.

22 Dec 2011
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Thao T Kwan

22 Dec 2011
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Thao T Kwan

22 Dec 2011
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Thao T Kwan

22 Dec 2011
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Thao T Kwan

22 Dec 2011
21 CFR 211.192

Quality control unit review of records

Cited by Thao T Kwan

Inspected site

NINatren Inc.Thousand Oaks, United States

Inspection team

TTThao T Kwan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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