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Form 483

Patheon Puerto Rico, Inc. Form 483, 2018-05-31

FDA issued a Form 483 to Patheon Puerto Rico, Inc. on 2018-05-31 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Patheon Puerto Rico, Inc. · Manati, United States · Issued May 31, 2018

Overview

  • 3 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.

31 May 2018
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Libia M Lugo

31 May 2018
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Libia M Lugo

31 May 2018
21 CFR 211.130(b)

Unlabeled filled containers controls

Cited by Libia M Lugo

Inspected site

PPPatheon Puerto Rico, Inc.Manati, United States

Inspection team

LMLibia M Lugo

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.130(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited 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 3 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