IGMPI India



Italian API Maker Receives FDA Warning Letterdue to lack of data control

US FDA issued a Warning Letter on 7th July to Trifarma for violating Good Manufacturing Practices Standards at their facility in Rozzano, Italy.According to FDA, Trifarma "deleted all electronic raw data supporting its high performance liquid chromatography (HPLC) testing of all API products released to the US market." Such tests are used to characterize each substance and determine its identity and composition. Moreover, Trifarma failed to retain basic chromatographic information such as injection sequence, instrument method or integration method for the tests.

FDA also cited other data related concerns in its letter.Basic GMP provisions were not met in the lab.FDA inspectors found that Trifarma lacked controls to prevent "unauthorized manipulation" of the company's raw data as all laboratory employees were granted full privileges to the computer systems. Equipment in the lab such as the HPLC and the GC lacked active audit trail functions to record changes to data, including information on original results, the identity of the person making the change, and the date of the change. The company did not document any training of production employees on the production operations they performed.

The Warning Letter states that the problems at Trifarma'sRozzano facility uncovered during the January inspections were similar to those that were found in a November 2013 inspection of the company's CerianoLaghetto, Italy facility. FDA further added that until all alleged deviations were corrected, it would withhold approval for any drug made with the company's APIs, and it might refuse entry of the company's products into the US.