Failure to Adhere to Established Production Control Guidelines


JCB Laboratories LLC
Issued on:
Inspection Dates:
13 Aug 2018 to 14 Sep 2018
7335 W. 33rd St. North, Wichita, KS 67205
  • Michele Perry-Williams
  • Norman K Starks

Detailed Analysis

Key Observations

  • The observation highlights a systemic failure to adhere to written production and process control procedures across various functions within the firm, suggesting a need for comprehensive review and reinforcement of SOP compliance, training, and oversight.

Possible Root Cause :

  • Lack of adherence to established SOPs for various functions including label changes, manufacturing operations cessation, complaint investigations, visual inspections, adverse drug experience reporting, and changes resulting from system software updates.
  • Insufficient training or oversight leading to non-compliance with SOPs.
  • Ambiguities or deficiencies in SOPs leading to inconsistent application or misunderstanding.
  • Inadequate change control processes to document and review changes in procedures or operations.

Corrective Action:

  • Review and reinforce training on SOP compliance for all relevant personnel.
  • Conduct a comprehensive review of existing SOPs for clarity, comprehensiveness, and relevancy, making revisions where necessary.
  • Enhance change control processes to ensure all changes are documented, reviewed, and approved according to SOPs.
  • Implement routine audits to ensure adherence to SOPs and identify areas for improvement.

Preventive Action

  • Develop regular training refreshers on SOPs and change control procedures for all employees involved in production and process control functions.
  • Establish a clear and robust system for tracking and managing customer complaints and adverse drug experiences, ensuring timely investigation and reporting.
  • Improve oversight mechanisms to ensure consistent adherence to SOPs, including more frequent audits and real-time monitoring.
  • Revise the existing SOPs to include explicit instructions and criteria for decision-making processes, reducing ambiguity and ensuring uniform application.
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