A medical device firm recently received a 483 from FDA for failing to integrate their CAPA and Customer Complaint Programs.
The firm had customer complaints that were connected to open CAPA investigations, but did not “determine if the complaints opened are part of the same issue described in the open CAPAs.”
The specific 483 observations reads:
….Procedures for corrective and preventive action have not been adequately established.
Specifically, per the firm’s CAPA SOP the firm is required to analyze, evaluate, and investigate non conformances and potential non conformances to the product, process, or quality system. The firm failed to evaluate for potential corrective action 32 Leaking Complaints, 30 Power Issue Complaints, 92 Battery Issue Complaints, 57 Flow Rate Complaints, and 56 Air in Line Complaints of the 503…pump complaints reported over the last 18 months. The firm currently has open CAPAs for each of these error descriptions. The firm failed to determine if the complaints opened are part of the same issue described in the open CAPAs.”
FDA expects integration between CAPA and the complaint program because complaints are the real-time data feed informing the complete picture to evaluate CAPA effectiveness. FDA guidance on CAPA and customer complaints can be found in 21 CFR 820.198 and 21 CFR 820.100.
According to GMP Trends® Annual Reports, observations pertaining to CAPA (21 CFR 820.100) have been in the top 5 observations cited by the FDA each year for the last 5 years.
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For more information on implementing CAPA programs, refer to the following: FDA guidance document Corrective and Preventative Actions (CAPA) and FDA presentations CAPA Basics, CAPA within the Pharmaceutical Quality System.
