The FDA this week released a warning letter it sent to ARB Medical concerning its production of polymeric surgical meshes.
The agency knocked ARB Medical for marketing the product without appropriate clearance, and ran down a list of issues that arose after an inspection of its facilities in December.
Included in the warning letter were 8 separate deficiencies the federal watchdog requested to be fixed, according to the FDA press release.
Noted in the list of issues were failures to adequately evaluate according to established procedures, a failure to review and approve design outputs before release, design validation failures, incoming product acceptance procedure failures, complaint review failures, FDA reporting failures and medical device reporting failures.
Of specific concern to the FDA inspector were failures to review and evaluate complaints formally, with the investigator noting 4 different complaints received without appropriate action taken to investigate the complaints.
The FDA requested that the company address the violations noted and respond within 15 days.