FDA Outlines Concerns At Zimmer Biomet
February 3, 2017 at 7:53 p.m.
By Dan [email protected]
The document was issued after the agency performed a site inspection at the Zimmer Biomet facility over several weeks beginning Sept. 12, according to the FDA.
Reports about the details started surfacing earlier this week.
A copy of the report that was sent to David J. Kunz, Zimmer Biomet’s senior vice president of global quality assurance, regulatory affairs and clinical affairs, can be found online.
According to the FDA, a 483 is issued to companies following inspections when investigators have observed conditions viewed as regulatory violations.
Among the observations, the document said buildings are not of suitable design to perform necessary operations, and it found evidence of the company’s failure to establish procedures for design control and failure to adequately establish procedures to control environmental conditions.
The 58 pages are heavily redacted and include details on 14 observations.
One of those — termed a “repeat observation” — covers more than 20 pages. It involves suggestions that “a process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.”
In that observation, the FDA report looks at the lack of “validations involving the cleaning process governed by work instructions for a range of products including metal hips, knees and sports medicine devices, among others.”
In December, Zimmer Biomet responded to the report through the FDA, saying it was taking steps to “address certain regulatory compliance gaps at the legacy Biomet operation in Warsaw.”
The statement added that Zimmer Biomet “remains confident in the quality, safety and efficacy of all of its products. No patient safety concerns have been identified with any of the products manufactured at the site.”
Zimmer Biomet did not respond immediately this morning to a request for further comment.
The move by the FDA appears to be rare in its extent, according qmed.com, which points to a report issued by Larry Biegelsen, an analyst for Wells Fargo.
“The bottom line is, this is one of the longest and most serious 483s our consultant has ever seen and he believes it is likely to result in (Zimmer Biomet) receiving a warning letter,” Biegelsen is quoted saying in a report by qmed.com.
News of the FDA report comes a week after Zimmer Biomet announced Robert D. Delp would replace Stuart G. Kleopfer as president, Americas.
Orthopedics This Week also reported the company has made several recent management changes, including a new senior vice president of global operations and logistics and a new vice president of quality assurance.
Zimmer Biomet also confirmed layoffs this week as a result of restructuring. No figures on the number of jobs affected were released by the company.
The document was issued after the agency performed a site inspection at the Zimmer Biomet facility over several weeks beginning Sept. 12, according to the FDA.
Reports about the details started surfacing earlier this week.
A copy of the report that was sent to David J. Kunz, Zimmer Biomet’s senior vice president of global quality assurance, regulatory affairs and clinical affairs, can be found online.
According to the FDA, a 483 is issued to companies following inspections when investigators have observed conditions viewed as regulatory violations.
Among the observations, the document said buildings are not of suitable design to perform necessary operations, and it found evidence of the company’s failure to establish procedures for design control and failure to adequately establish procedures to control environmental conditions.
The 58 pages are heavily redacted and include details on 14 observations.
One of those — termed a “repeat observation” — covers more than 20 pages. It involves suggestions that “a process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.”
In that observation, the FDA report looks at the lack of “validations involving the cleaning process governed by work instructions for a range of products including metal hips, knees and sports medicine devices, among others.”
In December, Zimmer Biomet responded to the report through the FDA, saying it was taking steps to “address certain regulatory compliance gaps at the legacy Biomet operation in Warsaw.”
The statement added that Zimmer Biomet “remains confident in the quality, safety and efficacy of all of its products. No patient safety concerns have been identified with any of the products manufactured at the site.”
Zimmer Biomet did not respond immediately this morning to a request for further comment.
The move by the FDA appears to be rare in its extent, according qmed.com, which points to a report issued by Larry Biegelsen, an analyst for Wells Fargo.
“The bottom line is, this is one of the longest and most serious 483s our consultant has ever seen and he believes it is likely to result in (Zimmer Biomet) receiving a warning letter,” Biegelsen is quoted saying in a report by qmed.com.
News of the FDA report comes a week after Zimmer Biomet announced Robert D. Delp would replace Stuart G. Kleopfer as president, Americas.
Orthopedics This Week also reported the company has made several recent management changes, including a new senior vice president of global operations and logistics and a new vice president of quality assurance.
Zimmer Biomet also confirmed layoffs this week as a result of restructuring. No figures on the number of jobs affected were released by the company.
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