USFDA Flags Lapses at Eugia Pharma’s Hyderabad Plant

The USFDA has issued a warning letter to Aurobindo Pharma's subsidiary, Eugia, for significant manufacturing shortcomings at its Telangana-based facility. The violations include data inaccuracies, falsified records, and inadequate sterilization processes. Aurobindo Pharma asserts there will be no impact on current US supplies and pledges to work with USFDA to enhance compliance.

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

The US Food and Drug Administration (USFDA) has issued a warning letter to Eugia Pharma Specialities CEO Yugandhar Puvvala, highlighting data inaccuracies in production and process simulation. The letter, dated after an inspection that took place between January 22 to February 2, 2024, cited flaws in laboratory records and falsified environmental monitoring data.

In addition to problems with production data, the USFDA noted that records for equipment cleaning, disinfection, and sterilization were incomplete and inaccurate. According to the warning letter, the company did not establish or follow proper written procedures to prevent microbiological contamination in drug products encapsulated as sterile.

The US health regulator has requested a detailed corrective action plan from Eugia Pharma, covering root causes of data integrity failures and steps to ensure reliable data generation. Aurobindo Pharma has asserted that existing supplies to the US market remain unaffected and reiterated its commitment to working closely with USFDA to rectify the issues.

The USFDA stated that it might withhold approval of new applications or supplements listing the firm as a drug manufacturer until all deviations are fully addressed. They require a written response within 15 working days detailing actions taken to correct the violations and prevent recurrence. Post-correction, the FDA will re-inspect to confirm compliance with CGMP standards.

(With inputs from agencies.)