Inadequate Cleaning and Disinfection Practices


Innovative Intrathecal Solutions, Inc.
Issued on:
Inspection Dates:
10 Feb 2020 to 20 Feb 2020
41538 Eastman Dr Ste A, Murrieta, CA 92562-8007
  • Rumany Penn

Detailed Analysis

Key Observations

  • The absence of established and followed procedures for handling complaints indicates a critical gap in the company's Quality Management System, potentially affecting product quality and customer safety.

Possible Root Cause :

  • Lack of a systematic approach to handling complaints which could indicate a gap in the Quality Management System. Absence of standard operating procedures (SOPs) might result from insufficient understanding of regulatory requirements or oversight in establishing comprehensive processes. The company might also lack a culture that emphasizes the importance of customer feedback in quality assurance and continuous improvement.

Corrective Action:

  • 1. Develop and implement comprehensive SOPs for managing both written and oral complaints regarding a drug product, ensuring they meet FDA regulations under 21 CFR 211.198(a).
  • 2. Train relevant personnel on the new SOPs to ensure they are understood and followed.
  • 3. Establish a centralized system for logging and tracking complaints to ensure all are reviewed, investigated, and resolved promptly.
  • 4. Perform a retrospective review of past customer complaints to identify any previously overlooked issues and take necessary corrective actions.

Preventive Action

  • 1. Incorporate periodic reviews of complaint handling procedures into the internal audit schedule to ensure ongoing compliance.
  • 2. Implement continuous training programs for employees to reinforce the importance of proper complaint handling and staying up-to-date with any changes in regulations or internal procedures.
  • 3. Enhance quality culture by promoting transparency and the importance of customer feedback in improving product safety and efficacy.
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