Alembic Pharma (BOM:533573, NSE:APLLTD) received a Form 483 with four observations from the US Food and Drug Administration following a routine inspection at its API-I and API-II facilities in Panelav, Gujarat, according to a Saturday filing on the local bourse.
The inspection, which ran from May 26 to May 31, was unannounced and focused on current good manufacturing practices (cGMP), the company said in a filing.
None of the observations relate to data integrity, and management believes they are addressable. Alembic said it will respond to the regulator within the stipulated timeline.
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