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Form 483

Pacira Pharmaceuticals, Inc. Form 483, 2014-02-10

FDA issued a Form 483 to Pacira Pharmaceuticals, Inc. on 2014-02-10 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Pacira Pharmaceuticals, Inc. · San Diego, United States · Issued February 10, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

10 Feb 2014
21 CFR 211.103

Actual vs. theoretical yields not determined

Cited by Virgilio F Pacio

10 Feb 2014
21 CFR 211.180(e)

Records reviewed annually

Cited by Virgilio F Pacio

Inspected site

PPPacira Pharmaceuticals, Inc.San Diego, United States

Inspection team

VFVirgilio F Pacio

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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