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USFDA sends warning to Eugia over manufacturing violations at Telangana facility
Industry News- Aug 26,24
The regulatory body noted that Eugia failed to maintain complete laboratory records essential for compliance with established specifications and standards.
The US Food and Drug Administration (USFDA) has issued a warning to Aurobindo Pharma's subsidiary, Eugia, for significant manufacturing lapses at its facility in Telangana. In a letter addressed to Yugandhar Puvvala, CEO, Eugia Pharma Specialities, the USFDA highlighted the company’s failure to ensure the accuracy of data related to production and process simulation.
The regulatory body noted that Eugia failed to maintain complete laboratory records essential for compliance with established specifications and standards. During an inspection of the Patancheru, Sangareddy, Hyderabad-based plant from January 22 to February 2, 2024, the USFDA identified several issues, including the falsification of environmental monitoring records for aseptic filling lines and incomplete records for equipment cleaning, disinfection, and sterilisation.
In addition to these concerns, the USFDA found that Eugia had not established and followed appropriate written procedures to prevent microbiological contamination of drug products claimed to be sterile. The warning letter described these lapses as significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals.
The USFDA has requested a detailed corrective action plan from Eugia, outlining how the company intends to ensure the reliability and completeness of all data generated, including analytical data and manufacturing records. The letter also demands a comprehensive explanation of the root causes of these data integrity issues.
The regulatory body warned that it might withhold approval of new applications or supplements listing Eugia as a drug manufacturer until all deviations are fully addressed and compliance with CGMP is confirmed. The USFDA also indicated that it may re-inspect the facility to verify the completion of corrective actions.
An Aurobindo Pharma spokesperson responded, stating that there is no impact on existing supplies to the US market and that the company remains committed to working closely with the USFDA to enhance its compliance measures.
The warning letter serves as a formal notification of the violations and requires the company to correct the problems and provide a timeline for their resolution. The USFDA will then review the company’s corrective actions to ensure they are adequate.
(moneycontrol)
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