Piramal Pharma on Saturday said that the US Food and Drug Administration (FDA) conducted a pre-approval inspection (PAI) and good manufacturing practices (GMP) inspection of Piramal Pharma’s Sellersville (US) facility from December 19 till January 13. At the conclusion of the inspection, the company said the US FDA issued a Form-483, with two observations. The observations were classified under VAI (Voluntary Action Indicated) and do not relate to data integrity.
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