Aurobindo Pharma has announced that the US Food and Drug Administration (FDA) has completed its inspection at APL Healthcare's Unit-IV manufacturing facility. The regulatory review, conducted from December 08 to December 17, 2025, identified five procedural observations that require the company's formal response.

FDA Inspection Details

The inspection at APL Healthcare's Unit-IV facility, located at Palchur village and part of Palepalem Village Naidupet Mandal, SPSR Nellore District, Andhra Pradesh, has been concluded by the US FDA. The regulatory body conducted a comprehensive review of the manufacturing operations and compliance protocols at the wholly-owned subsidiary facility.

Regulatory Observations and Company Response

At the end of the inspection, the FDA issued a Form 483 with five observations that are procedural in nature. Aurobindo Pharma has confirmed that it will respond to the US FDA within the stipulated timelines for all identified observations.

The company emphasized its commitment to maintaining the highest quality manufacturing standards at all of its facilities across the globe. The pharmaceutical manufacturer will need to submit detailed responses explaining how it plans to address the procedural issues identified during the inspection.

Financial and Operational Impact

According to the company's regulatory disclosure, this development does not have any impact on the financial operations of the facility. The observations are procedural in nature and do not affect the manufacturing capabilities or revenue generation from the Unit-IV facility.

The company has committed to keeping the stock exchanges informed of any further information relating to this inspection in the future, as part of its ongoing compliance with SEBI listing regulations.

Aurobindo Pharma has announced the completion of a US FDA inspection at Unit-V of Apitoria Pharma Private Ltd, with regulatory authorities issuing a Form 483 containing three observations.

FDA Inspection Details

The US Food and Drug Administration has concluded its inspection of the pharmaceutical manufacturing facility, following standard regulatory oversight procedures. The inspection focused on Unit-V operations of Apitoria Pharma Private Ltd, a subsidiary of Aurobindo Pharma.

Regulatory Compliance Process

Form 483 represents the FDA's standard documentation process for communicating observations made during facility inspections. The document typically outlines areas where the agency believes the company may not be in compliance with FDA regulations or standards.

The three observations noted in the Form 483 will require the company to provide responses and corrective action plans to address the regulatory concerns identified during the inspection process.

Industry Context

FDA inspections are routine regulatory activities designed to ensure pharmaceutical manufacturing facilities maintain compliance with current Good Manufacturing Practices (cGMP) and other applicable regulations. The completion of such inspections represents part of the ongoing regulatory oversight process for pharmaceutical companies operating in the US market.