The US Food and Drug Administration (USFDA) has issued a warning to Aurobindo Pharma’s subsidiary, Eugia Pharma Specialities, citing significant lapses in manufacturing practices at its plant in Telangana. In the letter addressed to Eugia Pharma Specialities CEO Yugandhar Puvvala, the USFDA highlighted the company’s failure to maintain accurate production data and process simulations.
The regulator pointed out that the laboratory records did not include complete data from all necessary tests, which is crucial to ensure that the products meet established specifications and standards. The USFDA conducted an inspection of the Patancheru (Mandal), Sangareddy, Hyderabad facility between January 22 and February 2, 2024, during which it uncovered several issues.
The agency noted that Eugia Pharma did not ensure the accuracy of data in records related to both production and process simulations, particularly media fills. Additionally, it was found that operators had falsified environmental monitoring records for multiple aseptic filling lines, including the documentation of air sample locations and particle counts, which were not collected from their recorded locations.
The letter also mentioned that the company failed to maintain complete batch production and control records for each batch of drug products manufactured. Moreover, records related to equipment cleaning, disinfection, and sterilization were found to be incomplete and inaccurate.
A spokesperson for Aurobindo Pharma commented on the matter, stating, “There is no impact on the existing supplies to the US markets.” The spokesperson added that the company is committed to working closely with the USFDA to enhance its compliance measures on an ongoing basis.
The USFDA further criticized Eugia Pharma for not establishing and following appropriate written procedures designed to prevent microbiological contamination in drug products claimed to be sterile. This includes the lack of validation for all aseptic and sterilization processes. The violations cited in the warning letter reflect significant breaches of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
The USFDA has requested a detailed corrective action plan from Eugia Pharma, outlining how the company intends to ensure the reliability and completeness of all data generated, including analytical data and manufacturing records. The agency also demanded a comprehensive explanation of the root causes behind the data integrity issues and evidence that the company’s corrective actions are thorough and appropriate in scope.
The letter warned that the FDA might withhold approval of new applications or supplements listing Eugia Pharma as a manufacturer until all deviations are fully addressed and the company is in compliance with CGMP regulations. The USFDA may also conduct a follow-up inspection to verify the completion of corrective actions.
Eugia Pharma has been instructed to respond to the USFDA in writing within 15 working days, detailing the steps taken to correct the deviations and prevent their recurrence. The warning letter emphasized that the company must correct the identified problems within a specified timeframe, after which the FDA will review the corrections to ensure they are adequate.
