Atlas

Form 483

Novocol Pharmaceutical of Canada, Inc. Form 483, 2014-11-11

FDA issued a Form 483 to Novocol Pharmaceutical of Canada, Inc. on 2014-11-11 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Novocol Pharmaceutical of Canada, Inc. · Cambridge, Canada · Issued November 11, 2014

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.

11 Nov 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Joel D Hustedt

11 Nov 2014
21 CFR 211.42(c)(10)(v)

Cleaning System

Cited by Joel D Hustedt

11 Nov 2014
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Joel D Hustedt

Inspected site

NPNovocol Pharmaceutical of Canada, Inc.Cambridge, Canada

Inspection team

JDJoel D Hustedt

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited 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