FDA hits Italian drug manufacturer for destroying data
- In January, the FDA inspected Trifarma’s manufacturing plant in Rozzano, Italy and subsequently cited the company for good manufacturing practice (GMP) violations.
- Trifarma received a letter from the FDA on July 15 that cited specific standards violations.
- Until the violations are corrected, the FDA will not approve any drugs made with Trifarma’s active pharmaceutical ingredients (APIs).
The FDA says it found many problems when it inspected Trifarma’s manufacturing facility, almost all related to data and the manner in which it is collected and stored. The agency says Trifarma deleted all electronic raw data related to the high performance liquid chromatography (HPLC) testing and failed to guard against potential unauthorized manipulation of raw data. Trifarma is working to address these issues, in part by implementing audit trails throughout its operations.
- Regulatory Affairs Professional Society Italian API Manufacturer Warned by FDA Over Missing Data