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Form 483

BWXT Medical Ltd. Form 483, 2011-08-31

FDA issued a Form 483 to BWXT Medical Ltd. on 2011-08-31 with 1 public-safe observation.

483· Form 483 issued1 observation

BWXT Medical Ltd. · Ottawa, Canada · Issued August 31, 2011

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.

31 Aug 2011
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Christopher T Middendorf

Inspected site

BMBWXT Medical Ltd.Ottawa, Canada

Inspection team

CTChristopher T Middendorf

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)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 1 observation

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