Aurobindo Pharma has received warning letter from US Food and Drug Administration (USFDA) for violating current good manufacturing practice norms at its Telangana-based plant. The significant violations included failure to evaluate the potential effect that changes may have on the quality of intermediates and API.
Hyderabad-based drug firm failed to fully evaluate whether increasing acceptable starting material would impact the quality of the API. The USFDA also pointed at the failure of the company's quality unit to ensure that critical deviations are investigated and resolved.
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.
