fda warning
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Hospitals
FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk
SILVER SPRING, Md., Nov. 13, 2018 /PRNewswire/ — The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its…
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Globus Medical Reveals FDA Warning Letter Over MicroFuse Putty
Globus Medical says the FDA issued a warning letter over its MicroFuse bone-growth putty. Globus Medical (NYSE:GMED) said the FDA issued…
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Spine
Stryker Recalls Spinal Implant, Gets ‘Deadly’ FDA Label
Stryker is recalling lots of a device used in spinal surgeries, and the FDA has assigned its most serious tag…
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GS Medical Packaging Warning Notes Several Missing Procedures
GS Medical Packaging has received an FDA warning letter because it lacked several procedures, including an MDR procedure for its…
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Medtronic Neuromodulation Business Gets FDA Warning Letter
Medtronic Inc.’s (MDT) business for neuromodulation devices recently received a Food and Drug Administration warning letter related mainly to the…
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When The FDA Comes Knocking, Is Your Company Prepared?
It’s become clear in the first four months of this year that the FDA is ratcheting up its efforts to…
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Stryker announces resolution of FDA Warning Letter related to Its New Jersey manufacturing facility
Stryker Corporation today announced that it has been informed by the U.S. FDA that the actions undertaken by the company…
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