Atlas

Form 483

Patheon UK Limited Form 483, 2016-12-06

FDA issued a Form 483 to Patheon UK Limited on 2016-12-06 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Patheon UK Limited · Swindon, United Kingdom · Issued December 6, 2016

Overview

  • 6 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.

6 Dec 2016
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Marcus F Yambot

6 Dec 2016
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Marcus F Yambot

6 Dec 2016
21 CFR 211.42(c)

Defined areas of adequate size for operations

Cited by Marcus F Yambot

6 Dec 2016
21 CFR 211.42(c)

Defined areas of adequate size for operations

Cited by Marcus F Yambot

6 Dec 2016
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Marcus F Yambot

Inspected site

PUPatheon UK LimitedSwindon, United Kingdom

Inspection team

MFMarcus F Yambot

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 6 observations

The full inspection record, as Atlas holds it, 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