FDA Warns Indian Company for Deleting, Backdating Records

The FDA slammed drug and active pharmaceutical ingredient (API) maker RPG Life Sciences for deleting and backdating records and lacking a “robust quality system.” A warning letter calls on the Indian company to hire a third-party auditor to fix quality issues at its Ankleshwar and Navi Mumbai plants. The quality lapses appear to have already hurt the company, which was put on import alert by the agency last month.
Drug GMP Report