Lack of Documented Responsibilities and Procedures in Quality Control Units

Overview

Company:
Empower Clinic Services LLC dba Empower Pharmacy
Issued on:
05-Aug-22
Feinumber:
3011887629
Inspection Dates:
18 Jul 2022 to 05 Aug 2022
Location:
5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041-5251
Investigators:
  • Margaret M Annes
  • Suzanne N Vallez

Detailed Analysis

Key Observations

  • The wide-ranging deficiencies noted across the quality control unit's responsibilities suggest a systemic issue with the quality management system, emphasizing the need for comprehensive procedural overhauls and enhanced personnel training.

Possible Root Cause :

  • Lack of established quality control procedures in writing, leading to non-compliance with regulatory requirements.
  • Incomplete or ineffective complaint and deviation investigation processes, indicating a possible lack of resources, training, or oversight.
  • Delayed or absent reporting of adverse events, potentially due to inadequate surveillance and reporting systems.
  • Insufficient documentation on API and excipient suitability, which could stem from inadequate supplier qualification and raw material testing procedures.
  • Absence of procedures to reset cleanroom conditions post events like shutdown or maintenance, likely due to a lack of understanding of environmental control requirements in aseptic processing areas.
  • Failure to implement CAPA, suggesting possible issues with the firm’s CAPA system, including tracking and accountability mechanisms.
  • Not testing incoming raw materials like L-Citrulline for endotoxins as per CAPA agreements, reflecting a failure in following through with CAPA resolutions and weaknesses in the supplier qualification process.

Corrective Action:

  • Draft, review, and implement comprehensive written procedures covering all aspects of the Quality Unit’s operations including complaint handling, deviation management, adverse event reporting, and supplier qualification.
  • Conduct immediate and thorough investigations into past instances of deviations, non-conformances, and out-of-specification results, with emphasis on root cause analysis and implementation of effective corrective actions.
  • Update or establish a robust adverse event reporting system ensuring timely FDA notifications.
  • Perform a comprehensive review and revision of supplier qualification procedures, particularly focusing on critical raw materials like APIs and excipients. Include endotoxin testing as a mandatory release criterion for high-risk raw materials like L-Citrulline.
  • Develop and validate cleanroom re-certification procedures post-maintenance/shutdown activities, ensuring these are clearly documented and adhered to.
  • Enhance the CAPA system to ensure all identified actions are timely implemented, verified for effectiveness, and properly documented.

Preventive Action

  • Implement regular training programs for all employees on the updated procedures and their roles within the quality control unit.
  • Introduce a periodic quality management review process, ensuring all procedures remain effective and are fully followed.
  • Adopt a risk management approach to prioritize and manage the resolution of deviations, non-conformances, and complaints.
  • Institute routine audits of supplier and internal processes to ensure continuous compliance and process improvement.
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