US Food and Drug Administration (USFDA) has pulled up Aurobindo Pharma's subsidiary Eugia for manufacturing lapses at its Telangana-based plant. USFDA has pointed out that the company failed to ensure the accuracy of data for production and process simulation. 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. USFDA inspected the Patancheru (Mandal), Sangareddy, Hyderabad-based plant from January 22 to February 2, 2024.
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. There is no impact on the existing supplies to the US markets.
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.
A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations.
Aurobindo Pharma is engaged in manufacturing pharmaceutical products. It offers active pharmaceutical ingredients, intermediates and generic formulations like astemizole, domeperidone and omeprazole; anti-infective, oral and sterile antibiotics, pain management and osteoporosis segments.
