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BRIEF-Zimmer Biomet received warning letter from FDA on May 31 - SEC Filing
2016年6月6日 / 中午12点22分 / 1 年前

BRIEF-Zimmer Biomet received warning letter from FDA on May 31 - SEC Filing

June 6 (Reuters) - Zimmer Biomet Holdings Inc :

* On May 31, 2016, company received a warning letter dated may 27, 2016 from FDA

* Warning letter does not restrict production or shipment of company’s products from Montreal facility

* Warning letter does not require withdrawal of any product from marketplace

* Warning letter does not restrict company’s ability to seek 510(k) clearance of products

* Warning letter related to observed non-conformities with current good manufacturing practice requirements at co’s facility in Montreal

* Intends to respond fully and in a timely manner to FDA’s warning letter

* FDA’s concerns set forth in warning letter can be resolved without a material impact to company’s financial results

* FDA inspected company’s Montreal facility in January 2016

* Per warning letter, premarket approval applications for class iii devices to which quality system regulation deviations are related will not be approved

* Since conclusion of inspection, company has provided detailed responses to FDA as to its corrective actions Source text for Eikon: (1.usa.gov/1Peg3ld) Further company coverage: (Bengaluru Newsroom: +1-646-223-8780)

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