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Regulatory News | 19 January 2017 | By Zachary Brennan
Just a day before Rep. Tom Price (R-GA) was grilled by senators over his links to the medical device company Zimmer Biomet, the US Food and Drug Administration (FDA) released a Form 483 for the company’s Detroit-based site with 14 observations.
The 58-page, heavily-redacted Form 483 follows the site inspection from 12 September 2016 to 22 November 2016. The first observation – on sterilization validation and a “test that has not been adequately validated” – and the seventh observation – on procedures for cleaning process monitoring were noted as repeat observations from an inspection in June 2014.
FDA investigators also found the company’s water system “has processed water for use in manufacturing, cleaning, and passivating medical devices, but your firm has not adequately monitored this system's water quality in accordance with established procedures.”
In addition, the agency found Zimmer has “no objective evidence” that conductivity and total organic carbon monitoring has occurred since the system was installed.
The agency also found that the site’s procedures governing the placement of devices on quality hold and their removal have not been documented. For instance, FDA said that for 11 of 15 release transactions reviewed, Zimmer was “unable to provide documentation showing the detailed reason for the quality hold, reason and approval of its release, or the lot numbers within the scope of the hold/release.”
FDA also observed that the company’s procedures for corrective and preventive action, process control procedures and procedures for receiving, reviewing and evaluating complaints have not been adequately established.
Zimmer Biomet did not respond to a request for comment.
Tags: 483, Biomet, CAPA, Form, Zimmer