FDA slams Aurobindo subsidiary for mfg flaws

Hyderabad: The US health regulator has pulled up Aurobindo Pharma’s subsidiary Eugia for manufacturing lapses at its Telangana-based plant.

In a warning letter to Eugia Pharma Specialities CEO Yugandhar Puvvala, the US Food and Drug Administration (USFDA) pointed out that the company failed to ensure the accuracy of data for production and process simulation. “Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards,” USFDA stated.

The US health regulator said it inspected the Patancheru (Mandal), Sangareddy, Hyderabad-based plant from January 22 to February 2, 2024. “You failed to ensure the accuracy of data in records for both production and process simulations (media fills),” USFDA noted.

Besides, the operators also falsified environmental monitoring records for the multiple aseptic filling lines, including for viable active air samples and non-viable particle counts which were not collected in their documented location, it added.

The USFDA also stated that the company failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug products produced. “You failed to ensure records for equipment cleaning, disinfection, and sterilisation are complete and accurate,” the latter noted.

When contacted an Aurobindo Pharma spokesperson said: “There is no impact on the existing supplies to the US markets.” The company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis, the spokesperson added.

According to USFDA, the company also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. The warning letter summarises significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, it said.

A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. USFDA sought a detailed corrective action plan that describes how the company intends to ensure the reliability and completeness of all the data generated including analytical data and manufacturing records.