Texas Devicemaker Cited for Issues With Internal Audits

Possible conflicts of interest among those who conducted quality audits at Unysen Health’s Mansfield, Texas facility netted the firm a Form 483 from the FDA.

The agency scolded the firm for having its chief operating officer (COO) conduct quality management internal audits, noting the firm’s internal audit procedure stated that “auditors are assigned to ensure independence from the audited activity. If an auditor works in that department being audited, they may not audit their own work.”

Additionally, the firm did not date its audit reports, making it impossible for the agency investigator to determine if it conducted audits as frequently as required.