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Medical Devices / Inspections and Audits

Texas Devicemaker Hit for Complaint Handling

May 17, 2019
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The FDA cited Austin, Texas device manufacturer Alafair Biosciences for failing to correctly handle complaints.

In a Dec. 19-20, 2018 inspection, the FDA investigator found that the company received at least four complaints about its VersaWrap tendon protection device not having enough solution during procedures, but it did not initiate a corrective or preventive action (CAPA) to fix the problem, the agency said.

In addition, the company received eight complaints about VersaWrap tears during surgical procedures since July 2018, but only launched a CAPA on Dec. 17, according to the inspection report.

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