FDA Cites Italian API Plant for Deleted Data

Source: RAPS

Jul 15, 2014

The U.S. FDA has sent Trifarma S.p.A.'s manufacturing facility in Rozzano, Italy a Warning Letter for allegedly deteting data, thus indicating that the FDA's GMP-scrutiny is not limited to just India.

The letter to the Italian manufacturer follows a January 2014 inspection where inspectors found several GMP violations, including the deletion of raw data from testing performed to ensure API quality and a failure to prevent unauthorized access or changes to data.

"Your firm’s lack of data control causes us to question the reliability of your data," the FDA stated in its letter.

Early this year, amidst an FDA crackdown on India drugmaker compliance issues, the FDA sent letters to India drugmakers Wockhardt and Sun Pharma for similar data trail compliance violations.

Read the Warning Letter
Read the RAPS story