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BRIEF-U.S. FDA issues warning letter to Magellan Diagnostics
2017年10月23日 / 晚上6点09分 / 1 个月前

BRIEF-U.S. FDA issues warning letter to Magellan Diagnostics

Oct 23 (Reuters) - ‍U.S. Food and Drug Administration :

* ‍U.S. Food and Drug Administration says issued a warning letter to Magellan Diagnostics Inc​

* ‍U.S. FDA - Magellan diagnostics has until Nov. 10, to notify FDA about specific steps co has taken to address violations, to prevent them from recurring​

* U.S. FDA says in letter that Magellan marketed significantly modified versions of two of its blood lead testing systems without FDA’s required approval​

* ‍U.S. FDA - Inspection showed Magellan altered two of its blood lead testing systems after they were already FDA cleared

* ‍U.S. FDA - During inspection investigators observed violations, including failing to submit medical device reports regarding discrepancies in test results​ Source text for Eikon: Further company coverage:

我们的标准:汤森路透“信任原则”
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