Missing Health Hazard Determinations and Justifications


Abbott Laboratories dba Abbott Nutrition
Issued on:
Inspection Dates:
31 Jan 2022 to 18 Mar 2022
901 N Centerville Rd, Sturgis, MI 49091-9302
  • Alexandra A Carrico
  • John N Woodall
  • Elizabeth P Mayer
  • Danny Tuntevski
  • Christi L Bellmore
  • Brittany A Mckenzie
  • Daniel B Arrecis
  • Rohn R Robertson
  • Liliya V Bubiy
  • Ana E Morales
  • Nicholas E Boyd
  • Adam M True

Detailed Analysis

Key Observations

  • The failure to conduct thorough investigations into consumer complaints related to adverse health events, particularly cases of illness and infant death, highlights a significant deficiency in the complaint handling process and potentially compromises product safety and consumer trust.

Possible Root Cause :

  • Lack of clear guidelines or adherence to SOPs for conducting thorough investigations of consumer complaints.
  • Inadequate sensitization on the criticality of differentiating between adverse health events and product non-conformance.
  • Potential gaps in the communication between the complaint handling team and quality control or medical safety surveillance teams.
  • Lack of a robust system for root cause analysis that considers health hazards.

Corrective Action:

  • Conduct a thorough review of SOPs related to complaint management and investigations to include explicit criteria for determining health hazards.
  • Provide targeted training to complaint handling, quality control, and medical safety surveillance teams on the importance of identifying potential health hazards and proper documentation.
  • Implement a cross-functional team approach for investigating complaints, especially those associated with adverse health events, to ensure comprehensive review and analysis.
  • Enhance the complaint investigation procedure to include mandatory testing of retain samples for complaints associated with health concerns.

Preventive Action

  • Update the complaint handling SOPs to clarify the circumstances under which microbial analysis of retain samples must be performed.
  • Develop a checklist or decision tree to aid in the determination of health hazards during complaint investigations.
  • Institute regular audits of complaint investigations to ensure adherence to updated SOPs and proper documentation practices.
  • Implement a continuous training program on complaint handling, with emphasis on recognizing and addressing potential health hazards.
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