June 4, 2020 / 5:54 AM / a month ago

BRIEF-Aurobindo Pharma Says 'Form 483' Issued With 9 Observations After USFDA Inspection Of Dayton, New Jersey Plant

June 4 (Reuters) - Aurobindo Pharma Ltd:

* ‘FORM 483’ HAS BEEN ISSUED WITH 9 OBSERVATIONS AFTER US FDA INSPECTION OF DAYTON, NEW JERSEY PLANT

* USFDA INSPECTED AUROLIFE PHARMA LLC’S ORAL SOLID MANUFACTURING FACILITY IN DAYTON, NEW JERSEY FROM JAN 13 TO FEBRUARY 12

* RECEIVED A LETTER FROM USFDA CLASSIFYING INSPECTION AS ‘OFFICIAL ACTION INDICATED

* OAI CLASSIFICATION MAY NOT HAVE ANY MATERIAL IMPACT ON EXISTING REVENUE, SUPPLIES OF US BUSINESS OR PIPELINE PRODUCTS AT THIS JUNCTURE Source text for Eikon: Further company coverage:

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