US FDA Inspection At Alembic Pharmaceuticals Formulation Facility At Panelav

We would like to inform that the United States Food and Drug Administration (US FDA) has conducted an inspection at Alembic Pharmaceuticals Formulation Facility located at Panelav from 12th March, 2018 to 20th March, 2018. This was a scheduled inspection and at the end of the inspection, the US FDA issued a Form 483 with 3 observations.

None of the observations are related to data integrity or repetitive in nature.

The Company is preparing the response to the observations, which will be submitted to the US FDA shortly.

We request you to kindly take the same on record.

Thanking you,

Yours faithfully,
For Alembic Pharmaceuticals Limited



R. K. Baheti
Director - Finance & CFO

Pdf Link: US FDA Inspection At Alembic Pharmaceuticals Formulation Facility At Panelav

Source : BSE - www.bseindia.com

Published on March 21, 2018

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