The Food and Drug Administration (FDA) laid out 14 objectionable conditions and practices observed during a recent inspection of medical device manufacturer Zimmer Biomet’s Warsaw, Indiana, plant.
The FDA took issue with the plant’s sterilization process, the results of which could not be verified during subsequent inspections. Another issue involved inadequately established procedures for monitoring cleaning processes. Environmental conditions were also not adequately implemented.
The FDA also cited the medical company for not monitoring its water quality in according with established procedures. The plant has been using processed water in its manufacturing and cleaning of medical devices for more than a decade. The FDA also complained about Zimmer Biomet’s inadequate procedures for handling complaints.
Issues first arouse with Zimmer Biomet after the company disclosed in a June filing with the U.S. Securities and Exchange Commission that it had received a warning letter the month prior from the FDA regarding violations of the current Good Manufacturing Practices (cGMP) at its plant in Montreal.
The violations outlined in the agency’s warning letter were identified during a January 2016 inspection of the Montreal facility. Until the violations at that plant are corrected, the FDA said it would not grant any premarket approval applications for Class III medical devices from the company. Zimmer Biomet said that it does not currently have any premarket approval applications with the FDA.