Zimmer Biomet Receives Warning Letter From FDA
August 27, 2018 at 4:44 p.m.
Zimmer Biomet Receives Warning Letter From FDA
By Staff Report-
Zimmer Biomet formally replied to the letter, saying it had taken action. But in a re-inspection last year, the FDA indicated it was still not satisfied with the changes, according to a report by MassDevice.com.
Zimmer said it received a warning letter Aug. 24 that detailed “observed non-conformities with current good manufacturing practice requirements of the quality system regulation” at the North Campus facility, according to a report by MassDevice.com.
The website quotes Zimmer Biomet: “We take the matters identified in the warning letter seriously and are in the process of preparing a written response” within 15 business days, noting its plans to accept the FDA’s proposal for a regulatory meeting.
The warning letter doesn’t bar the company from selling any devices made at the North Campus plant, it said.
Zimmer Biomet formally replied to the letter, saying it had taken action. But in a re-inspection last year, the FDA indicated it was still not satisfied with the changes, according to a report by MassDevice.com.
Zimmer said it received a warning letter Aug. 24 that detailed “observed non-conformities with current good manufacturing practice requirements of the quality system regulation” at the North Campus facility, according to a report by MassDevice.com.
The website quotes Zimmer Biomet: “We take the matters identified in the warning letter seriously and are in the process of preparing a written response” within 15 business days, noting its plans to accept the FDA’s proposal for a regulatory meeting.
The warning letter doesn’t bar the company from selling any devices made at the North Campus plant, it said.
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