BA Research India Ltd. – FDA EIR, Oct 22, 2010

An FDA inspection of BA Research India Ltd., located in Bodakdev, Ahmedabad, India, was conducted from October 18 to October 22, 2010. This was an initial, high-priority pre-approval data validation inspection for Abbreviated New Drug Applications (ANDAs), specifically focusing on bioequivalence studies. The regulatory framework for this inspection involved C/P 7348.001, pertaining to the validation of clinical data supporting generic drug applications. The inspection covered the firm's participation in two bioequivalence protocols, BA09500002 and LUTA-09100, both involving Ethinyl Estradiol/Levonorgestrel tablets. No formal inspectional observations (FDA-483) were issued. However, discussions with management highlighted two areas for improvement: the need to maintain site visit logs within archived study data and to ensure staff record exact numerical data, such as temperatures, for precision. Management agreed to implement both required actions, confirming they would add log copies to future study files and retrain personnel on accurate data entry. The inspection concluded without any refusals or other significant issues.