March 28, 2018 / 7:30 AM / 23 days ago

BRIEF-Alkem Laboratories Gets Form 483 With 13 Observations After U.S. FDA Inspection At Co's Amaliya Facility​

March 28 (Reuters) - Alkem Laboratories Ltd:

* GOT A FORM 483 WITH 13 OBSERVATIONS AFTER US FDA INSPECTION AT CO’S MANUFACTURING FACILITY AT AMALIYA, DAMAN​

* SAYS ‍ US FDA HAD CONDUCTED INSPECTION AT THE FACILITY FROM MARCH 19-27

* SHALL PUT TOGETHER DETAILED RESPONSE WITH ADEQUATE CORRECTIVE AND PREVENTIVE MEASURES TO ADDRESS US FDA OBSERVATIONS​

* ‍IN RESPONSE TO FORM 483 BY FDA AT CO'S ST LOUIS FACILITY, CO HAS SUBMITTED CORRECTIVE AND PREVENTIVE ACTION PLAN ​ Source text: bit.ly/2I9G2xd Further company coverage:

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