The plant makes the iAssist and Zimmer PSI knee systems, the Zimmer PSI shoulder and the Navitrack software system, according to a warning letter dated May 27 and released June 30. The FDA said the inspections, from January 25 through January 28, turned up 9 quality system violations that were issued in a Form 483 notice. Zimmer Biomet responded in February and March, but the March 31 letter missed the 15-business-day deadline and was not reviewed (the agency said it would take a look at it when it reviews the company’s response to the warning letter).
The agency said the initial response dated Feb. 19 failed to address several of the problems, including a lack of procedures for implementing corrective and preventive actions; ensuring equipment calibration, inspection maintenance; receiving and tracking medical device reports; failing to file correction or removal within 10 business days; and failing to record the reason for not reporting corrections or removals.
Zimmer Biomet also lacked procedures for the receipt and evaluation of complaints and failing to ensure that materials and supplies conform to requirements, the FDA said. The company also failed to maintain device master records and lacked procedures for quality audits, according to the warning letter.
The company had 15 days from receipt of the letter to let the FDA know what steps it’s planning or has taken to address the violations, including a timetable for changes that can’t be made immediately.