Unresolved Unexplained Discrepancies


Charles River Laboratories, Inc.
Issued on:
Inspection Dates:
27 Dec 2023 to 04 Jan 2024
358 Technology Dr, Malvern, PA 19355-1315
  • Brandy N Lepage

Detailed Analysis

Key Observations

  • The firm's failure to effectively monitor and investigate deviations in environmental controls within ISO 6 classified areas highlights a significant gap in the quality management system, particularly in the areas of environmental monitoring and risk assessment.

Possible Root Cause :

  • Inadequate procedure for detecting deviations through the internal facility monitoring system (BAS) that failed to detect large variations in differential pressure.
  • Insufficient risk assessment to determine the impact of environmental control failures on cell banking produced since the areas passed the last certifications.
  • Lack of prompt and comprehensive investigation into the root causes and impacts of the ISO 6 classified areas failing air flow and/or pressure measurements.

Corrective Action:

  • Revise the procedure for environmental monitoring to ensure that the BAS system can effectively detect large variations in differential pressure.
  • Perform a comprehensive risk assessment on all batches produced since the last successful certification of affected ISO 6 classified areas to determine potential product impact.
  • Strengthen the investigation procedures to ensure they adequately address both the root cause and potential impact on product quality and safety of environmental control failures.

Preventive Action

  • Enhance training for personnel involved in environmental monitoring to ensure proper detection and handling of deviations.
  • Implement more frequent and robust internal audits of the environmental control and monitoring systems to detect discrepancies before they impact product quality.
  • Update and validate the BAS system to ensure efficient and accurate monitoring of environmental conditions in ISO classified areas.
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