Devices

Multiple QS Violations Cited at Zimmer Montreal Facility

David McFarland

— 1 min read
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A 1/25-1/28 FDA inspection at Zimmer Biomet Holding’s manufacturing facility in Montreal, Canada, found multiple violations of the agency’s Quality System Regulation in the manufacturing of the iAssist knee system, Zimmer PSI shoulder system, Zimmer PSI knee system, and the Navitrack system. A just-released 5/27 Warning Letter says that specific violations listed on an FDA-483 included: 

  •          failing to establish and maintain procedures for implementing corrective and preventive action;
  •          failing to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
  •          failing to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements;
  •          failing to maintain device master records;
  •          failing to establish and maintain adequate procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, including provisions for handling, preserving, and storing equipment so that its accuracy and fitness for use are maintained;
  •          failing to establish and maintain procedures for quality audits and to conduct such audits to assure that the quality system complies with the established quality system requirements and to determine quality system effectiveness;
  •          failing to adequately develop, maintain, and implement written Medical Device Reporting procedures;
  •          failing to submit a Report of Correction or Removal for a medical device correction or removal initiated to reduce a risk to health or to remedy a violation of the Federal Food, Drug, and Cosmetic Act caused by the device that may present a health risk; and
  •          failing to keep a record containing a justification for not reporting the correction or removal action to FDA containing conclusions and any follow-ups, and reviewed and evaluated by a designated person.

The company’s responses either were inadequate or could not be evaluated, the letter says. Zimmer was told to respond with a list of specific steps taken to correct the violations and prevent their recurrence, with documentation for each step and a timetable for completion.

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