Missing Replies in Complaint Records

Overview

Company:
SterRx, LLC
Issued on:
04-Nov-21
Feinumber:
3010840309
Inspection Dates:
21 Sep 2021 to 04 Nov 2021
Location:
141 Idaho Ave, Plattsburgh, NY 12903-3987
Investigators:
  • Edmund F Mrak
  • Lori M Newman

Detailed Analysis

Key Observations

  • The lack of written responses to complainants concerning investigation findings indicates a significant gap in the customer complaint handling process. This deficiency undermines trust and transparency between the firm and its customers.

Possible Root Cause :

  • Lack of adherence to established procedures for handling customer complaints and adverse events.
  • Inadequate complaint records management system, leading to incomplete documentation.
  • Ineffective communication and follow-up procedures with complainants.

Corrective Action:

  • Review and update SOP QAS205 "Customer Complaints and Adverse Events" to include requirements for issuing a formal, final written response to complainants concerning investigation findings.
  • Implement a complaint records management system or enhance the existing system to ensure it captures all necessary information, including final written responses to complainants.
  • Train relevant personnel on updated procedures and the importance of comprehensive documentation and communication with complainants.

Preventive Action

  • Conduct regular audits of the customer complaint handling process to ensure adherence to procedures and complete documentation.
  • Establish a periodic review mechanism for SOPs related to customer complaints and adverse events to ensure they remain effective and relevant.
  • Implement a validation check within the complaint records management system to flag incomplete complaint records for review and completion.
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