warning letter
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Financial
CMS sent out warnings to hospitals failing at price transparency. Some still aren’t sure where they land
by Dave Muoio | May 10, 2021 The Centers for Medicare & Medicaid Services has sent its first wave of warning letters out…
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Hospitals
FDA issues warning letter to Smith & Nephew regarding questionable operations at plant in Andover, MA
By Varun Saxena The FDA slapped Smith & Nephew ($SNN) with a warning letter for quality-control violations at its Andover,…
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Spine
NuVasive hit with FDA warning letter over spine device
On March 12, the FDA issued a warning letter to NuVasive for selling Affix Spinous Process Plate systems for uses…
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California implant makers get FDA warnings
Two Murrieta, CA-based implant makers have been called on the carpet by the FDA for lacking quality control over their manufacturing…
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Spinal fusion device draws FDA warning letter
Spinal device company Lucero Medical has received awarning letter from the U.S. Food and Drug Administration, primarily over documentation and quality control issues.…
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Extremities
Synthes gets warning letter over complaint management
Swiss medical device manufacturer Synthes has received a warning letter from U.S. regulators taking issue with the company’s management of…
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Anulex Technologies Receives Warning Letter
Public Health Service Food and Drug Administration 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 WARNING LETTER VIA UPS EXPRESS…
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Alphatec Spine, Inc. 1/11/11
WARNING LETTER VIA UPS EXPRESS JAN 11 2011 Paula Morgan, RAC Senior Director, Regulatory Affairs Alphatec Spine, Inc. 5818 El…
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Biomet Receives FDA Warning Letter, Seeks Resolution with FDA
WARSAW, Ind. – (Business Wire) On July 28, 2010, Biomet received a Warning Letter from the U.S. Food and Drug…
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Stryker Announces Resolution of FDA Warning Letter Related to Its Mahwah, New Jersey Manufacturing Facility
KALAMAZOO, Mich., March 23, 2010 /PRNewswire via COMTEX/ — Stryker Corporation (NYSE: SYK) today announced that it has been informed…
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Frontier Devices received an FDA Warning Letter
Aubrey Clint Folsom, Jr. President, CEO, and Owner Folsom Metal Products, Inc. DBA Frontier Devices, Inc. 153-A Cahaba Valley Parkway…
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