Immunostics Draws 483 for Complaint Handling, Procedural Issues

January 26, 2018

The FDA cited drug manufacturer Immunostics over CAPA procedure issues, inadequate complaint handling, calibration deficiencies and other problems at the firm’s Eatontown, New Jersey facility.

During a November inspection, the investigator found that numerous CAPA procedures were either not established or not followed adequately.

The agency official found inadequate training in procedures to correct or prevent recurrences of nonconformities or quality system issues. Employees were marked as properly retrained after committing a violation, but the retraining was not documented.

The facility’s medical device reporting and product recall procedures did not define the procedure for filing electronic reports, only including provisions for submitting hardcopy MDRs to the agency. In addition, product performance complaints the firm received were not entered into the firm’s complaint handling system.

The facility also lacked adequate design change procedures. Specifically, it did not require design changes be validated.

Two instances of failure to routinely calibrate facility equipment were noted by the agency, including calibration of a temperature gauge on the sealing machine.

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