Italian API Manufacturer Warned by FDA Over Missing Data

Posted 15 July 2014 | By Alexander Gaffney, RAC 

Italian API Manufacturer Warned by FDA Over Missing Data

An Italian active pharmaceutical ingredient (API) manufacturer has received a Warning Letter from the US Food and Drug Administration (FDA) chiding the company for allegedly deleting all of the data meant to ensure that its product was manufactured to specifications.

The 15 July 2014 letter follows a January 2014 inspection of Trifarma S.p.A.'s manufacturing facility in Rozzano, Italy.

There, FDA said its inspectors found several violations of its regulations on good manufacturing practices (GMP).

For example, FDA said it discovered that Trifarma "deleted all electronic raw data supporting your 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, and FDA often looks for this data to determine if any out-of-specification ingredients were produced or released.

"Your firm’s lack of data control causes us to question the reliability of your data," FDA wrote, adding that the company lacks a company-wide backup system for its data.

FDA also cited other data-driven concerns in its letter. For example, regulators alleged that Trifarma lacked controls to prevent "unauthorized manipulation" of the company's raw data. "All laboratory employees were granted full privileges to the computer systems," FDA's letter states. The company is now working on fully implementing audit trails throughout its operations, it wrote in a response to FDA.

The Warning Letter notes that the problems at Trifarma's Rozzano facility are similar to those found in a November 2013 inspection of the company's Ceriano Laghetto, Italy facility.

"It is essential that your firm implement a robust global quality system," FDA told Trifarma.

FDA added that until all alleged deviations were corrected, it would withhold approval for any drug made with the company's APIs, and that it might refuse entry of the company's products into the US.


FDA Warning Letter to Trifarma

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