US FDA Warning Letter Hits Strides On Data Integrity
Was blue binder of batch records in scrap yard a sign of deeper problems?
Even after the US FDA warns Strides on uncontrolled records destruction and poor OOS investigations at its Puducherry plant, firm remains confident in its US market growth projections.
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COMPETES Act also includes enhanced penalties for drug makers who falsify or destroy records, power for the FDA to recall harmful drugs, funding for drug manufacturing technology and additional supply chain flexibility efforts.
Strides' newly-appointed CEO, R Ananthanarayanan, sees no reason to change course as the firm's current strategy continues to yield positive results. The company posted a 29% increase in third-quarter revenues on the back of 62% growth in the US.
Newly-appointed CEO at Strides, R Ananthanarayanan, sees no reason to change course as current strategy continues yielding positive results. Company posts 29% increase in third-quarter revenues on the back of 62% growth in the US