FDA Asks Zimmer For ‘Voluntary Compliance’A recent visit by the Food and Drug Administration to Zimmer Biomet’s Warsaw manufacturing facility left the business with a list of things to bring into what the FDA called “voluntary compliance.”
The FDA Form 483, which can be found on Zimmer Biomet’s website, listed 11 “observations” of things the company needs to bring into compliance. The report was based on four FDA inspectors visiting the facility April 9-24.
The online version of the report has key points redacted. A FDA spokesperson said the redactions were necessary to protect processes proprietary to Zimmer Biomet.
The observations are:
• Procedures for corrective and preventive action have not been adequately established.
• A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.
• Risk analysis is inadequate.
• Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
• Procedures to control environmental conditions have not been adequately established.
• Procedures have not been established to control product that does not conform to specified requirements.
• Procedures for acceptance activities have not been adequately established.
• Procedures for training and identifying training needs have not been established.
• Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
• Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
• Procedures to ensure equipment is routinely calibrated, inspected, checked and maintained have not been adequately established.
Of the 11 observations, eight were repeated from an inspection done Sept. 12 to Nov. 22, 2016.
The FDA spokesperson, who asked not to be identified, said, “These are observations. They’re not comprehensive whatsoever. They are not a final agency action.
“While not all companies receive a Form 483, these are among the most common things that we put out from a compliance perspective.”
The spokesperson added Zimmer Biomet is far from any sort of legal action to require compliance.
The Times-Union asked Zimmer Biomet for a response to this report, and Monica Kendrick, vice president, corporate communications, sent a link to a web page with the following statement:
“As previously disclosed, the U.S. Food and Drug Administration recently performed an inspection of Zimmer Biomet Holdings Inc.’s North Campus manufacturing facility in Warsaw. At the conclusion of the inspection on April 24, 2018, the FDA issued a Form 483 with 11 inspectional observations. None of the observations identified a specific issue regarding the performance of any particular product and all products continue to be manufactured by the facility. Zimmer Biomet stands behind the safety of the products manufactured at the Warsaw North Campus.
“The company notes that this reinspection occurred as it continues to execute against its approximately two-year quality remediation plan at the Warsaw North Campus. Zimmer Biomet believes that considerable progress has been made over the past year, but more work remains to be completed. The company takes the FDA’s observations very seriously and, as part of the ongoing two-year remediation effort, continues to work diligently with independent consultants to address both existing and new Form 483 observations.
“Quality excellence is an integral aspect of Zimmer Biomet’s commitment to the patients and surgeons who rely on its products every day. The company’s primary focus has always been, and continues to be, patient safety. Zimmer Biomet remains committed to operating a first-rate quality management system across its global manufacturing network and maintaining the quality, safety and efficacy of the products manufactured at the Warsaw North Campus facility.”
Kendrick said the company would have no further comment on the report.
The full report for the 2018 inspection can be found at http://investor.zimmerbiomet.com/news-and-events/news/2018/05-16-2018 or on the online version of this story. The company’s response to the 2016 inspection, along with a copy of the report, can also be found on the website. The response is dated Dec. 16, 2016.
