Inadequate Specifications for Components

Overview

Company:
Wood's Pharmacy, Inc., dba The Medicine Shoppe
Issued on:
15-Jan-15
Feinumber:
3004580127
Inspection Dates:
12 Jan 2015 to 15 Jan 2015
Location:
108 Main Street, Boones Mill, VA 24065
Investigators:
  • Tajah L Blackburn
  • Nebil A Oumer

Detailed Analysis

Key Observations

  • The failure to perform scheduled audits as per the organization's own procedures indicates systemic weaknesses in the quality management system, particularly in maintaining the internal audit program's integrity and effectiveness. Addressing this issue is crucial for ensuring continuous quality assurance and compliance.

Possible Root Cause :

  • Lack of a robust internal audit scheduling system to ensure audits are conducted as planned.
  • Possible oversight or lack of resources dedicated to performing internal audits according to the established schedule.
  • Inadequate prioritization of internal audit activities within the quality management system, leading to missed or delayed audits.

Corrective Action:

  • Implement or enhance an internal audit management system or software to track and alert for upcoming audits to ensure they are completed as scheduled.
  • Allocate additional resources, either by training current employees or hiring additional staff, to ensure audit schedules can be adhered to.
  • Review and maybe revise the internal audit process to ensure it is given the necessary priority within the quality management system, including top management's direct oversight on audit scheduling and completion.

Preventive Action

  • Establish a cross-functional audit committee to oversee the audit schedule and ensure adherence to all future audits.
  • Integrate regular reviews of audit schedules and completions into senior management meetings to maintain visibility and accountability.
  • Develop a training program for all relevant employees on the importance of internal audits and how they contribute to the overall efficacy of the quality management system.
View 483 Notice
350+ pharma facilities globally use Leucine
to stay compliant.
350+ pharma facilities globally
use Leucine
to stay compliant.
350+ Pharma
Facilities Globally
use Leucine
to stay compliant.
Speak with one of the expert consultants at Leucine to know how.
Schedule Demo