Critical Aseptic Processing Deviation


Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
Issued on:
Inspection Dates:
02 Aug 2022 to 11 Aug 2022
1826 Boy Scout Dr, Fort Myers, FL 33907-2113
  • Jennifer Lalama
  • Steven A Brettler

Detailed Analysis

Key Observations

  • The detection of Rhizopus, an objectionable organism, in an ISO 8 prep room adjacent to the ISO 5 aseptic processing area suggests a significant risk to product safety and indicates gaps in the environmental monitoring and CAPA processes.

Possible Root Cause :

  • Inadequate environmental monitoring program that failed to cover all critical areas adjacent to the ISO 5 classified aseptic processing area.
  • Lack of effective response protocol for when objectionable organisms are detected, indicating a gap in the CAPA system.
  • Insufficient training or awareness among staff about the importance of immediate action upon detection of contamination.

Corrective Action:

  • Re-assess and enhance environmental monitoring programs to ensure comprehensive coverage of all critical and adjacent areas to aseptic processing spaces.
  • Develop and implement a robust action plan for addressing microbiological contamination promptly, including the halt of production and evaluation of potentially affected product batches.
  • Retrain personnel on environmental monitoring and the significance of contamination findings, focusing on immediate actions and escalation procedures.

Preventive Action

  • Review and improve standard operating procedures (SOPs) related to environmental monitoring, including detailed actions and responsibilities upon detection of objectionable organisms.
  • Institute regular training sessions and drills for staff to respond to microbial contamination incidents effectively.
  • Enhance the CAPA system to ensure a timely and effective response to environmental monitoring alerts, including the investigation of root causes and implementation of long-term solutions.
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