FDA Issues Warning Letter to Globus Medical

Audubon, Pa.-based Gobus Medical Inc. disclosed that it received a warning letter from the U.S. Food and Drug Administration on Sept. 26. The letter flagged “deficiencies” in Globus’ response to a Form 483 warning the agency issued after inspecting the medical device company’s Audubon facility in May and June.

These deficiencies relate to the company’s Microfuse putty. The putty is a synthetic bone void filter product that combines Globus’ Microfuse granules with a resorbable polymer carrier. The warning letter does not restrict the company’s ability to manufacture or seek 510(k) clearance of products, company officials said.

“The company is currently addressing the deficiencies cited by the FDA in the warning letter and intends to work expeditiously to address each of the outstanding issues,” a company statement reads. “The company believes that the FDA’s concerns set forth in the warning letter can be resolved without a material impact to the company’s financial results. However, the company cannot give any assurances that the FDA will be satisfied with its response to the warning letter or its proposed resolution of the outstanding issues.”

Upon the announcement of the warning letter, Globus’ stock price took a dip. Share price closed on Friday, Oct. 10, just under $18 and was down by Tuesday, Oct. 15, to $17.36 in late-afternoon trading.