Aurobindo Pharma US FDA Inspection Ends With 3 Observations At Apitoria Pharma Plant
Aurobindo Pharma on Friday said a US Food and Drug Administration (US FDA) inspection at an active pharmaceutical ingredient (API) manufacturing facility operated by its wholly owned subsidiary Apitoria Pharma concluded with three observations. The inspection was conducted from August 24 to August 28 at Unit-VI of Apitoria Pharma in E-Bonangi Village, Parawada Mandal, in Andhra Pradesh’s…
US Food and Drug Administration (US FDA) inspectors concluded a three-day inspection at Aurobindo Pharma's Apitoria Pharma facility in Andhra Pradesh, India, on August 28. The facility, specifically Unit-VI in E-Bonangi Village, Anakapalli district, is an active pharmaceutical ingredient (API) manufacturing site. The three observations made during the inspection were characterized by Aurobindo Pharma as procedural in nature.
The pharmaceutical company assured it would submit its response to the US FDA within the specified time frame. The inspection follows a review of another Apitoria Pharma facility earlier in the week. While the specific details of the three observations were not disclosed by Aurobindo Pharma, the company reiterated its commitment to maintaining quality and regulatory compliance across its manufacturing operations.
This comes a week after Aurobindo Pharma's AuroPeptides subsidiary in Telangana underwent a separate US FDA review, resulting in one observation.
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