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Medical Devices / Inspections and Audits

FDA Cites Immunostics Over Complaint Handling, Procedural Issues

Jan. 29, 2018

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

During a November 2017 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.

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