Atlas

Form 483

Patheon Puerto Rico Inc. Form 483, 2013-03-28

FDA issued a Form 483 to Patheon Puerto Rico Inc. on 2013-03-28 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Patheon Puerto Rico Inc. · Caguas, United States · Issued March 28, 2013

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.

28 Mar 2013
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Rebecca Parrilla

28 Mar 2013
21 CFR 211.166(a)

Results not used for expiration dates, storage cond.

Cited by Rebecca Parrilla

28 Mar 2013
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Rebecca Parrilla

Inspected site

PPPatheon Puerto Rico Inc.Caguas, United States

Inspection team

RPRebecca Parrilla

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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