Zimmer Biomet Holdings Inc. (ZBH) said Monday that a subsidiary got a warning letter from the U.S. Food and Drug Administration last week regarding a manufacturing facility in Warsaw, Ind., the latest snag the company has hit over the same operation in the past couple of years.
The manufacturing facility the FDA has raised issues with is the North Campus manufacturing facility in Warsaw, the same city where Zimmer is headquartered.
“While the warning letter acknowledges our quality remediation plan and actions we’ve already taken to address the FDA’s inspectional observations, it notes violations that require additional action or explanation,” Zimmer said in a securities filing Monday, noting that the FDA wants to meet to “discuss the proposed corrections.”
Zimmer also said in the filing that “the warning letter does not restrict production or shipment of products from the Warsaw North Campus facility or require the withdrawal of any product from the marketplace.”
The FDA issued a Form 483 — a move that is taken if the FDA thinks regulations are being violated — following an inspection it did of the same facility in 2016. The FDA inspected the facility again in April of this year.
Zimmer said that it is “in the process of preparing a written response” to the FDA and that it is planning to reply within 15 days.
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