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Form 483

Unio Qumica Farmacutica Nacional SA Form 483, 2012-12-11

FDA issued a Form 483 to Unio Qumica Farmacutica Nacional SA on 2012-12-11 with 1 public-safe observation.

483· Form 483 issued1 observation

Unio Qumica Farmacutica Nacional SA · Guarulhos, Brazil · Issued December 11, 2012

Overview

  • 1 public-safe observation is 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.

11 Dec 2012
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Jose E Melendez

Inspected site

UQUnio Qumica Farmacutica Nacional SAGuarulhos, Brazil

Inspection team

JEJose E Melendez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

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  • 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