The United States Food and Drug Administration (US FDA) concluded its inspection of Aurobindo Pharma’s Unit-IV of APL Healthcare Limited on December 17, 2025. The inspection resulted in a ‘Form 483’ with 05 observations of a procedural nature. The company will respond to the US FDA within the specified timeframe and remains committed to upholding high-quality manufacturing standards across its facilities.
US FDA Inspection Completed
Aurobindo Pharma has announced the completion of the US Food and Drug Administration (US FDA) inspection at Unit-IV of APL Healthcare Limited, a wholly-owned subsidiary. The inspection took place from December 8 to December 17, 2025, at the facility located in Andhra Pradesh.
Details of the Inspection
At the conclusion of the inspection, a ‘Form 483’ was issued, outlining 05 observations. These observations are procedural. Aurobindo Pharma has stated they will address the FDA’s concerns within the stipulated timeframe.
Commitment to Quality Standards
Aurobindo Pharma emphasized its dedication to maintaining the highest quality manufacturing standards throughout all its facilities. The company will keep the stock exchanges informed about any significant developments related to this matter in the future.
Source: BSE
