Unreviewed Discrepancies and Batch Specification Issues


Central Admixture Pharmacy Services Inc
Issued on:
Inspection Dates:
10 Jul 2023 to 25 Aug 2023
7935 Dunbrook Rd Ste C, San Diego, CA 92126-6322
  • Jolanna A Norton
  • Rachel C Stanton
  • Doan N Singh
  • Xiaohui Shen

Detailed Analysis

Key Observations

  • The observation highlights a systemic issue with the quality unit's process for handling deviations, complaints, and discrepancies, suggesting a fundamental lack of rigor and robustness in the QMS. It emphasizes the need for immediate and broad-scale corrective and preventive actions to ensure product quality and patient safety.

Possible Root Cause :

  • Insufficient emphasis on identifying the root cause of deviations, leading to superficial or incomplete investigations.
  • Lack of adequately trained personnel or resources dedicated to conducting thorough investigations of deviations and implementing CAPAs.
  • Absence of a robust Quality Management System (QMS) that emphasizes the importance of investigating all discrepancies, regardless of their immediate impact.
  • Failure to establish and follow a rigorous protocol for evaluating the risk and potential impact of discrepancies on product quality and patient safety.
  • Delayed or inadequate responses to customer complaints, indicating a potential breakdown in communication and prioritization of customer feedback within the quality unit.
  • Inadequate environmental and process control, leading to repeated deviations such as microbial contamination and particulate matter in solutions.

Corrective Action:

  • Revisit and strengthen the existing procedures for discrepancy and failure investigations to ensure all steps—from discovery to resolution—are thoroughly documented and followed.
  • Conduct a comprehensive review and gap analysis of the current QMS, with a focus on improving the rigor and thoroughness of investigations.
  • Enhance training programs for personnel involved in conducting investigations, emphasizing the importance of root cause analysis and impactful CAPAs.
  • Implement an escalation process for discrepancies and failures that weigh the risk to product quality and patient safety as an element of the investigation priority.
  • Accelerate the investigation process for customer complaints, especially those suggesting critical product defects, and improve communication lines for prompt feedback and resolution.
  • Upgrade environmental and process controls to mitigate risks of microbial contamination and particulate matter, including the reassessment of cleanroom practices, equipment maintenance, and monitoring systems.

Preventive Action

  • Develop a more stringent oversight and follow-up protocol for ensuring that all identified CAPAs are effectively implemented and verified for efficacy over time.
  • Institute a regular training schedule for all relevant staff on the current industry standards and regulatory expectations for quality investigations and CAPA implementations.
  • Regularly review and update SOPs to incorporate lessons learned from past discrepancies and the latest industry best practices for quality management.
  • Integrate a risk management approach into the QMS, facilitating proactive identification and mitigation of potential product quality risks.
  • Foster a company-wide culture that values transparency and prompt reporting of potential quality issues to prevent minor discrepancies from evolving into systemic failures.
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