The US Food and Drug Administration (USFDA) has raised concerns over manufacturing lapses at Eugia Pharma Specialities, a subsidiary of Aurobindo Pharma, located in Telangana. In a warning letter addressed to Eugia's CEO, Yugandhar Puvala, the US health regulator highlighted several issues, including the company's failure to ensure data accuracy in production and process simulations. The USFDA's inspection, conducted at the Patancheru (Mandal), Sangareddy, Hyderabad facility between January 22 and February 2, 2024, revealed that laboratory records lacked complete data necessary for compliance with established specifications and standards.
The warning letter also cited instances where operators falsified environmental monitoring records for multiple aseptic filling lines, including misreported active air samples and particle counts. Additionally, the USFDA noted that Eugia failed to maintain comprehensive batch production and control records, and did not ensure the completeness and accuracy of records related to equipment cleaning, disinfection, and sterilization.
A spokesperson from Aurobindo Pharma responded by stating that the issues raised do not impact existing supplies to the US market. The company expressed its commitment to working closely with the USFDA to enhance compliance efforts continually.
The USFDA's letter emphasized that Eugia failed to establish and adhere to appropriate procedures to prevent microbiological contamination in products claimed to be sterile. The agency called for a detailed corrective action plan addressing the reliability and completeness of all data generated, including analytical and manufacturing records. The USFDA warned that until these deviations are resolved and compliance with Current Good Manufacturing Practice (CGMP) regulations is confirmed, the approval of new applications or supplements listing Eugia as a manufacturer may be withheld.
The USFDA has requested Eugia to respond within 15 working days, detailing the steps taken to address the violations and prevent their recurrence. The letter serves as a clear directive that the company must rectify these issues promptly, with the USFDA monitoring to ensure that the corrective actions are sufficient.
(Input from various sources)
(Rehash/Ankur Deka/MSM)
