Equipment Design Does Not Facilitate Intended Use

Overview

Company:
Chen Shwezin, Inc. dba Park Compounding
Issued on:
11-Sep-15
Feinumber:
3005256616
Inspection Dates:
31 Aug 2015 to 11 Sep 2015
Location:
280 N Westlake Blvd Ste 100, Westlake Village, CA 91362-7014
Investigators:
  • Liming Zhang
  • Darren S Brown

Detailed Analysis

Key Observations

  • The failure to conduct quality audits indicates a significant lapse in the firm’s quality management system, which could potentially compromise the overall quality and compliance of the product.

Possible Root Cause :

  • Lack of an internal quality audit schedule or failure to follow the established quality audit schedule.
  • Inadequate quality management oversight and lack of commitment to adhere to regulatory requirements.
  • Insufficient resources or personnel assigned to conduct quality audits.

Corrective Action:

  • Develop or revise the internal quality audit schedule to ensure comprehensive coverage of all quality system elements and operations.
  • Allocate sufficient resources and adequately trained personnel to perform quality audits in a timely and effective manner.
  • Implement mandatory training for the quality management team on the importance of quality audits and adherence to the established schedule.

Preventive Action

  • Establish a robust quality management system that prioritizes regular and systematic quality audits.
  • Incorporate quality audits into the performance metrics of the quality management team to ensure accountability.
  • Regularly review and update the quality audit schedule based on process changes, previous audit findings, and regulatory updates.
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