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Health Canada Non-Compliance Report: MS Pharma Inc., Canada

Establishment Name: MS Pharma Inc.

Activity(ies): Testing laboratory

  1. Only chemical testing is authorized. Microbial and sterility testing are not authorized.
  2. These Terms and Conditions are valid until such time as a revised Drug Establishment Licence is issued to MS Pharma Inc.

 

Summary of Observations
Observation Number Regulation Summary of Observation
1 C.02.015 - Quality Control
  • In the case where an original out-of-specification result was valid, a complete investigation of the deviation from specifications was not done.
  • Out of specification test results were not investigated to determine the cause of the problem.
  • Deficiencies were noted with the invalidation and re-testing done in a case of an out-of-specification test result that was clearly identified as a laboratory error.
  • In the case where an out-of-specification test result was valid, a complete investigation of the deviation from specifications was not done.
  • Out of specification test results were not investigated to determine the cause of the problem.
  • Deficiencies were noted with the invalidation and re-testing done in a case of an out-of-specification test result that was clearly identified as a laboratory error.
2 C.02.015 - Quality Control
  • Deficiencies were noted in the control of the IT equipment used for laboratory analysis.
3 C.02.015 - Quality Control
  • Deficiencies were noted in the labratory record keeping.
  • Deficiencies were noted with the preparation of reagents in the laboratory according to written procedures.
4 C.02.005 - Equipment
  • Deficiencies were noted with the calibration of equipment used for significant testing operations.
5 C.02.006 - Personnel
  • Not all personnel received continuing training in GMP principles relevant to their responsibilities.
  • Deficiencies were noted with the appointment of qualified personnel to carry out the duties of key personnel when these key people were absent.
6 C.02.015 - Quality Control
  • Deficiencies were found with the suitability of the laboratory control equipment for the testing procedures being done.

Inspection Outcome

Inspection resulted in a Non Compliant rating. The site has been determined to not be in Compliance with Part C, Division 2 of the Food and Drug Regulations.

Ratings are the result of observations made by Health Canada based on a reasonable belief at a particular point in time during the course of an inspection that the company was not conducting the regulated activity / activities in compliance with the Food and Drugs Act or its Regulations.

Measures taken by Health Canada

  • Non Compliant rating issued.