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.
A pre-approval inspection (PAI) is performed to contribute to the FDA's assurance that a manufacturing establishment named in a drug application is capable of manufacturing a drug, and that submitted data are accurate and complete.
Form-483 is given to a company's management following an inspection if the investigator found any situations that, in its opinion, might be considered violations of the Food, Drug, and Cosmetic Act and associated Acts.
The company said it was preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines. The company said it remains committed to maintaining the highest standards of compliance and will work closely with the agency to address all the observations comprehensively.
In another development, Granules India said its Gagillapur facility located at Hyderabad, Telangana, completed the US FDA's PAI during January 9-13 with three observations and the company will respond to these observations within the stipulated time period.
The company said it will respond to these observations within the stipulated time period. Gagillapur facility manufactures finished dosages (FDs) and pharmaceutical formulation intermediates (PFIs).
( With inputs from ANI )
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