Multiple law firms to investigate Globus Medical following FDA warning

Spinal Tech

At least four law firms have launched investigations into Globus Medical after the company received a warning letter from the FDA.

The Aug. 13 letter said that during an inspection into Globus Medical's Excelsius GPS spine robot, the devices did not conform to current manufacturing practice requirements. 

The letter also alleges that the company failed to implement corrective actions and investigate complaints.

The law firms are investigating whether Globus Medical and/or certain officers have violated federal securities laws or engaged in unlawful business practices. 

Following the disclosure of the FDA letter, the company's stock price fell more than 7%. 

Kirby McInerney LLP, Pomerantz LLP, Bronstein, Gewirtz & Grossman and Levi & Korsinsky, LLP each launched investigations. 

"Globus Medical has provided a formal response to the FDA, which included more requested details and action plans the company intends to perform to address the FDA's concerns," a spokesperson for the company told Becker's when initially asked about the letter. "This was completed within the required 15 days from issuance of the warning letter. We are confident that we have the data and documentation to support swift resolution in this matter."

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Webinars

Featured Whitepapers