Aurobindo Pharma has recently informed exchanges that the United States Food and Drug Administration (US FDA) completed an inspection of Unit-V, the API manufacturing facility of Apitoria Pharma Private Limited, its wholly owned subsidiary located in the Industrial Development Area, Chemical Zone at Pashamylaram Village in Telangana. The inspection was carried out over nearly two weeks, beginning on December 1 and concluding on December 12, 2025.
At the end of the review, the US FDA issued a Form 483 outlining three observations. According to the company, these observations are procedural in nature and do not point to any critical lapses in manufacturing or quality processes. Aurobindo Pharma has stated that it will submit its responses to the regulator within the prescribed timelines and will work closely with the agency to address the noted points.
The company stressed that the inspection outcome will not affect the operational performance of the facility. With no immediate financial or production impact, Aurobindo Pharma reiterated its focus on maintaining global-standard compliance and quality systems across all its manufacturing units. The communication received from the authority on December 12, 2025 marks the closure of the inspection phase, and the company expects a smooth resolution after submitting corrective action plans.
