Globus Medical Faces FDA Ire in New Warning Letter

Globus Medical Faces FDA Ire in New Warning Letter. Globus Medical Faces FDA Ire in New Warning Letter. The agency alleges multiple violations ...

Globus Medical, Inc. - 685606 - 07/15/2024 - FDA

We received responses from Daniel S. Paul, Senior Vice President of Quality Assurance, and Information Technology, dated March 28, 2024, and May ...

Globus Medical stock slides in response to FDA warning letter

The FDA today published a warning letter issued to Globus Medical (NYSE: GMED) alleging violations at a Pennsylvania facility.

Globus receives warning letter over spine navigation robot

The FDA said Globus delayed reporting complaints about misplaced screws, despite information that “reasonably suggests” the Excelsius GPS ...

The Law Offices of Frank R. Cruz Announces Investigation of Globus ...

On August 13, 2024, the FDA published a warning letter to Globus Medical regarding an inspection of the Company's Class II Excelsius GPS ...

FDA warns surgical robot maker Globus for QSR, MDR violations

The US Food and Drug Administration (FDA) has handed a warning letter to Globus Medical for failing to follow quality systems regulation (QSR) and medical ...

FDA Gives St. Jude Recall Class I Status - Medical Device and ...

FDA · Regulatory & Quality · Globus Medical Faces FDA Ire in New Warning LetterGlobus Medical Faces FDA Ire in New Warning Letter. byKatie Hobbins. Aug 13, 2024.

Globus Medical provides update on FDA warning over spine robot

Globus Medical CEO Dan Scavilla said the company has had "direct conversations" with the FDA related to its spine robot in a Nov.

Globus Medical Receives FDA Warning Letter, Says It Has Taken ...

Globus Medical said it received a warning letter from the Food and Drug Administration following an inspection of its facilities and that it has taken ...

FDA FOIA Log FY2015

Innocoll, Inc. PACIRA PHARMACEUTICALS - WARNING LETTER 09/22/2014 - 10/10 ... IntelGenx Corp. NOVARTIS CONSUMER HEALTH TRIAMINIC THIN STRIPS - APPROVAL LETTER ...

queryResult - FDA

All 483s, 483 responses, establishment inspection reports, and warning letter responses for Synthetopes in Conway, SC (FEI: 3007488106). ... Globus Medical at ...

united states securities and exchange commission

... warning letter, injunction, seizure, civil fine and criminal penalties. ... Globus Medical Ireland, Ltd. (“Globus Ireland”), a private limited company.

News We're Watching: Globus Warning Letter, FDA Clears ... - Citeline

This week, surgical robot maker Globus Medical got a warning letter from the US Food and Drug Administration; the FDA cleared a hemostatic ...

queryResult - FDA

Infinium Medical Inc. INFINIUM MEDICAL, LARGO FL - EIR, 483, WARNING LETTER. 235, 2018-8026, 10/04/2018, Evercore ISI, POLARITYTE, SALT LAKE CITY, UT 483 05/31 ...

MD+DI on LinkedIn: Medtronic Makes Bold Moves in AI with New ...

From FDA warning letters to major mergers, we've got you covered: ⚠ Globus Medical Faces FDA Ire in New Warning Letter Stryker CEO ...

Form 10-K for Globus Medical INC filed 02/21/2023 - Annual Reports

It is also possible that, if we obtain new FDA regulatory clearances or ... We received an FDA warning letter on October 31, 2018 related to ...

FDA FOIA Log FY2016

... NEW YORK, NY - EIR, 483, RESPONSE 03/19/2013 - 03/21/2013. 20, 2015-10018, 12 ... Nipro Diagnostics, Inc. STAT MEDICAL DEVICES, INC - RECS RE WARNING LETTER ...

Globus Medical Inc (GMED) Q3 2024 Earnings Call Highlights

Globus Medical Inc (GMED) reports a 63% revenue increase and record free cash flow, while addressing FDA concerns and integrating NuVasive's ...

Medical Device Supply Chains Project Report - ASPE

The purpose of this report is to provide an introduction to the supply chain for COVID-19 relevant medical devices and related challenges faced in ramping up ...

queryResult - FDA

The 483 (in electronic format) for Medical Devices & Rad Health inspection of New Star Lasers, Inc. ... Warning Letter. Withdrawn Closed w/o Charge. 716 ...