Addressing Failures in Reviewing Unexplained Discrepancies


Stokes Healthcare Inc. dba Epicur Pharma
Issued on:
Inspection Dates:
26 Sep 2023 to 25 Oct 2023
8000 Commerce Pkwy Ste 600, Mount Laurel, NJ 08054-2211
  • Christina K Theodorou
  • Yoriann M Cabrera Bartolomei
  • Ruben C Quintana

Detailed Analysis

Key Observations

  • The observation highlights systemic weaknesses in the firm's approach to handling discrepancies and failures, indicating potential risks to product quality and compliance.

Possible Root Cause :

  • Lack of a systematic and robust investigation process to identify definitive root causes for out-of-specification results.
  • Inadequate extension and connection of investigations to other potentially impacted lots.
  • Delay in timely completion of investigations, possibly indicating resource constraints, inadequacy in prioritization, or weaknesses in procedural adherence.

Corrective Action:

  • Review and revamp the existing investigation process to ensure thoroughness and timeliness, incorporating a root-cause analysis methodology that extends inquiries to other potentially impacted batches.
  • Implement training or re-training programs focused on investigative rigor and the importance of extending investigations to associated lots where applicable.

Preventive Action

  • Introduce a tracking and monitoring system for investigations to ensure adherence to stipulated timelines and to flag delays for immediate corrective measures.
  • Establish a continuous improvement program that reviews investigation outcomes, identifies trends, and formulates strategies to mitigate recurrence of similar discrepancies.
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