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.

Aurobindo Pharma has received regulatory feedback from the US Food and Drug Administration (FDA) following a comprehensive inspection at its subsidiary's manufacturing facility. The FDA has completed its inspection at Apitoria Pharma's Unit-V facility and issued Form 483 with three observations following the regulatory review.

FDA Inspection Details

The inspection was conducted at the API manufacturing facility of Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma. The facility is located at Industrial Development Area, Chemical Zone, Pashamylaram Village, Patancheru Mandal, Sangareddy District, Telangana.

Company Response and Impact

At the conclusion of the inspection, the FDA issued a Form 483 containing three observations. The company has not provided specific details about the nature of these observations. Aurobindo Pharma is expected to respond to the FDA within the stipulated timelines to address these observations.

According to the regulatory disclosure, this development does not have any impact on the operations of the facility. The company emphasized its commitment to maintaining the highest quality manufacturing standards at all of its facilities across the globe.

Regulatory Compliance Framework

Form 483 is a standard FDA document that lists conditions or practices that may constitute violations of the Food, Drug and Cosmetic Act and related regulations. The observations could relate to various aspects of the manufacturing process, documentation, or quality control procedures.

Aurobindo Pharma has assured stakeholders that it will keep the stock exchanges informed of any further developments relating to this inspection outcome in the future.