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Form 483

Natren Inc. Form 483, 2015-09-08

FDA issued a Form 483 to Natren Inc. on 2015-09-08 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Natren Inc. · Thousand Oaks, United States · Issued September 8, 2015

Overview

  • 4 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

8 Sep 2015
21 CFR 111.325(b)(2)(ii)

Records - document; results

Cited by Sonia R Peterson

8 Sep 2015
21 CFR 111.325(b)(2)(ii)

Records - document; results

Cited by Sonia R Peterson

8 Sep 2015
21 CFR 111.325(b)(2)(ii)

Records - document; results

Cited by Sonia R Peterson

8 Sep 2015
21 CFR 111.325(b)(2)(ii)

Records - document; results

Cited by Sonia R Peterson

Inspected site

NINatren Inc.Thousand Oaks, United States

Inspection team

SRSonia R Peterson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.325(b)(2)(ii)Cited across public-safe Form 483 observations4x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 4 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