Acumedia Manufacturers was cited in a Form 483 for inadequate corrective and preventive action (CAPA) procedures, failing to report a correction or removal, and other violations.
Following a visit to Acumedia’s Lansing, Mich., facility in late September and early October, inspectors reported that the firm failed to analyze all quality data sources to identify existing and potential causes of nonconforming product or other quality problems. For example, it did not consider nonconforming product as part of the regular analysis of quality data sources.
Acumedia also failed to investigate the cause of nonconformities related to the firm’s product, processes, and quality system. For example, the company initiated a CAPA report after receiving a complaint that a particular product did not have labels. However, it failed to conduct a root-cause investigation or take any other action, the FDA found.
In addition, Acumedia was cited for failing to identify the actions needed to correct and prevent the recurrence of quality issues. For example, it opened a CAPA report to address a failure to adequately establish procedures for monitoring and controlling a validated process. This report was determined to be effective and was closed on June 29, 2016. However, a review and a recommendation related to retrospective validation were never completed.
The company also issued correction letters to customers describing nonconforming products but did not notify the FDA. Moreover, its product recall procedures did not include a provision to document a justification for not reporting a correction or removal action.
Inspectors also reported that the firm did not establish adequate procedures for monitoring and controlling process parameters, ensure that equipment maintained an acceptable temperature range, or provide adequate resources to ensure that the quality control system met regulatory requirements.
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