Brief: Globus Medical Gets FDA Warning Following Inspection Of Facilities In Audubon, Pennsylvania

Globus Medical

13/08/2024 23:05

Aug 13 (Reuters) - Globus Medical Inc  GMED.N :
    * GLOBUS MEDICAL - ON JULY 16, RECEIVED WARNING LETTER FROM
U.S.
FDA FOLLOWING INSPECTION OF FACILITIES IN AUDUBON, PENNSYLVANIA
    * GLOBUS MEDICAL INC - IN WARNING LETTER, FDA CITED
DEFICIENCIES
IN RESPONSE LETTERS SENT BY COMPANY TO FDA FOLLOWING FORM 483
    * GLOBUS MEDICAL INC - LETTER DESCRIBES OBSERVED
NON-CONFORMITIES
IN ESTABLISHING AND MAINTAINING PRODUCT COMPLAINT PROCEDURES
    * GLOBUS MEDICAL INC - LETTER DOES NOT IDENTIFY ANY SAFETY
CONCERNS WITH USE OF EXCELSIUSGPS ROBOTIC SYSTEM
    * GLOBUS MEDICAL INC - HAVE TAKEN CORRECTIVE ACTIONS AND
PROVIDED
A COMPREHENSIVE AND TIMELY RESPONSE TO FDA
    * GLOBUS MEDICAL- BELIEVE FDA'S CONCERNS IN WARNING LETTER
HAVE
BEEN OR CAN BE RESOLVED WITHOUT MATERIAL IMPACT TO OPERATIONS OR
FINANCIAL RESULTS

Source text for Eikon:  ID:n0001562762-24-000209 
Further company coverage:  GMED.N 

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