FDA Cites Indian Drugmaker for Sterility, Testing Issues

The FDA flagged a Shilpa Medicare facility in Telangana, India for numerous violations including noncompliant labeling, sterility procedures and testing methods.

In a November inspection, the agency’s investigators found inadequate procedures for cleaning and maintaining equipment, including disassembly and reassembly procedures.

The firm also failed to thoroughly investigate all batch failures and discrepancies.  The inspection also revealed that numerous complaints regarding one of the firm’s products were not fully investigated, and the firm invalidated initial OOS results without adequate investigation.