Inadequate Review of Unexplained Discrepancies in Batch Records

Overview

Company:
LEESAR, INC
Issued on:
29-Oct-21
Feinumber:
3010166880
Inspection Dates:
18 Oct 2021 to 29 Oct 2021
Location:
2727 Winkler Ave, Fort Myers, FL 33901-9358
Investigators:
  • Jennifer Lalama
  • Kayla V Sprague

Detailed Analysis

Key Observations

  • Failure to thoroughly investigate and review discrepancies and OOS results before distribution of batches risks the release of potentially non-compliant products, impacting product quality and patient safety.

Possible Root Cause :

  • Insufficient quality control oversight on test results review and discrepancy investigations.
  • Lack of clear procedures or guidelines for handling out-of-specification (OOS) results and discrepancies.
  • Inadequate training of quality control and quality assurance personnel on discrepancy investigation and documentation.

Corrective Action:

  • Review and revise existing procedures on handling OOS results and discrepancies to include specific steps for investigation, documentation, and CAPA initiation.
  • Retrain quality control and quality assurance personnel on the revised procedures.
  • Re-evaluate all previously distributed batches with unexplained discrepancies or OOS results and take necessary actions based on findings.

Preventive Action

  • Implement routine audits on how OOS results and discrepancies are handled to ensure compliance with procedures.
  • Establish a continuous training program for quality control and quality assurance personnel on discrepancy investigation and OOS handling.
  • Enhance documentation practices to ensure thorough and traceable records of investigations and CAPAs.
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