US FDA finds issues at Aurobindo injectables facility

CDMO Aurobindo’s Telangana, India facility has been classified as Voluntary Action Indicated (VAI) following a Form 483 with seven observations.

Shreeyashi Ojha, Reporter

July 3, 2024

2 Min Read

The Eugia SEZ unit situated in Mahabubnagar District, Telangana – approximately 1,500 km south of New Delhi – was inspected by the US Food and Drug Administration (FDA) in February 2024, following which a Form 483 was issued by the regulatory authority.

The agency criticized Eugia, a contract development and manufacturing organization (CDMO) subsidiary of Indian drugmaker Aurobindo, for failing to follow written and process control procedures, citing various issues at the injectables facility.

Moreover, the observations noted that procedures to prevent microbiological contamination of sterile mug products were not followed, and equipment was improperly located, control procedures were not established, and there was no backup for data. Aseptic areas were inadequately cleaned, and employees lacked necessary training for manufacturing and processing drug products.

Like many manufacturers, Aurobindo Pharma is no stranger to receiving 483s citing GMP deficiencies. The firm’s API production plant in Sangareddy District, Telangana was classified as Official Action Indicated (OAI) by the regulatory authority in May 2024. In the same month, another plant in Andhra Pradesh was served a form 483 with one observation – procedural in nature. Whereas in April 2024, Aurobindo’s Alwar, Rajasthan facility received a 483 citing seven observations.

Aurobindo dealmaking

In other news, the firm has acquired Ace Laboratories through its subsidiary Agile Pharma. In a deal worth ₹17 crores ($227 million), the firm will provide quality control testing and analytical development services for chemical and microbiological analysis of pharmaceutical products, the filing said.

According to the firm, the acquisition is primarily intended to meet the company's business needs in the region. Edgware, UK-based Ace conducts 170 test batches and has a capacity to handle over 250 batches monthly.

In November 2023, Aurobindo’s other subsidiary CuraTeQ signed a limited Letter of Intent (LOI) with pharma giant Merck & Co. (known as MSD outside North America).

About the Author(s)

Shreeyashi Ojha

Reporter, BioProcess Insider

Journalist covering the manufacturing and processing sectors for biopharmaceuticals globally.  

Originally from India, I am a Londoner at heart. I have recently graduated from Goldsmiths, University of London.  

Feel free to reach out to me at: [email protected].

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