May 2, 2018 / 3:03 PM / 24 days ago

BRIEF-India's Biocon Says USFDA, European Regulator Issue Observations On Bangalore Plant

May 2 (Reuters) - Biocon Ltd:

* SAYS US-FDA COMPLETED PRE-APPROVAL INSPECTION OF STERILE DRUG PRODUCT PLANT IN BANGALORE AND ISSUED A FORM 483 WITH 7 OBSERVATIONS

* SAYS OBSERVATIONS ARE LARGELY PROCEDURAL AND AIMED AT CONTINUOUS IMPROVEMENT

* SAYS WILL RESPOND TO THE FDA WITH A CORRECTIVE AND PREVENTIVE ACTION PLAN IN A TIMELY MANNER

* SAYS HAS ALSO THIS WEEK RECEIVED PRELIMINARY REPORT FROM EUROPEAN REGULATOR POST INSPECTION OF BANGALORE STERILE DRUG PRODUCT PLANT

* SAYS EUROPEAN REGULATOR LISTS 6 MAJOR OBSERVATIONS WITH NONE CLASSIFIED AS CRITICAL

* SAYS WILL SUBMIT A CORRECTIVE AND PREVENTIVE ACTION PLAN TO EUROPEAN INSPECTION AGENCY WITHIN STIPULATED TIME PERIOD Source text for Eikon: Further company coverage: (Mumbai newsroom)

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