FDA cites Italian API maker for deleting all analytics

FDA inspections have uncovered a number of Indian companies that have manipulated data on their active pharmaceutical ingredients (APIs) and deleted test results that didn't conform to specifications, an issue that has led to warning letters and contributed to import alerts. Many of those makers have been in India, but a warning letter posted today for an Italian company shows the problem is universal.

The warning, sent July 7 to Trifarma in Milan, said FDA inspectors found the API maker deleted all electronic raw data supporting its high performance liquid chromatography (HPLC) testing on all API products it had shipped to the U.S. market. "Your firm's lack of data control causes us to question the reliability of your data," the warning letter said.

The company reponded that it has researching backup equipment since July 2013 and expects to have a system in place by the third quarter of this year but the FDA said that alone would not satisfy its concerns. The FDA pointed out that the problems uncovered during the January inspections were similar to issues inspectors uncovered during an inspection in November 2013 at the company's plant in Ceriano Laghetto, Italy. The agency said the company needs a comprehensive correction plan that includes retraining all of its employees to make sure that testing data is protected and audits trails are available for all of the products it sells in the U.S.

This kind of problem has factored into a series of import alerts against plants operated by some of India's biggest generic drugmakers. That includes Sun Pharmaceuticals, two plants operated by Ranbaxy Laboratories, as well as two Wockhardt plants that were banned last year by the FDA, as well as by European authorities.

- read the warning letter