Inadequate Investigation of Unexplained Discrepancies


Kilitch Healthcare India Limited
Issued on:
Inspection Dates:
12 Oct 2023 to 20 Oct 2023
Kilitch Healthcare India Limited, R - 904 905 T T C Industrial Road, Navi Mumbai, Maharashtra, 400706
  • Anastasia M Shields
  • Justin A Boyd

Detailed Analysis

Key Observations

  • The observation highlights a significant gap in the firm's quality control and complaint handling procedures, specifically in assessing potential microbial contamination risks. Addressing this gap is crucial to prevent the distribution of potentially contaminated batches and ensure patient safety.

Possible Root Cause :

  • Lack of a thorough microbial contamination assessment procedure for handling customer complaints.
  • Insufficient training or oversight on complaint investigation processes leading to inadequate assessment.
  • Inadequate or unclear criteria for escalating complaint investigations to assess potential microbial contamination.

Corrective Action:

  • Develop or revise a comprehensive procedure for the assessment of potential microbial contamination in response to customer complaints. This should include specific criteria for when additional microbial testing is warranted.
  • Conduct training sessions for staff involved in complaint handling and investigation to ensure understanding and implementation of the new or revised procedures.
  • Introduce a review step by the quality control unit for all complaint investigations related to potential microbial contamination before closing the investigation.

Preventive Action

  • Implement routine audits of completed complaint investigations to ensure adherence to procedures and identify areas for continuous improvement.
  • Enhance the initial complaint intake process to better capture details that could indicate potential microbial contamination, prompting earlier comprehensive investigations.
  • Establish a periodic review of the microbial assessment criteria based on emerging industry standards, regulatory guidance, and internal quality metrics.
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