Italian API manufacturer hit with FDA warning letter over data control

By Zachary Brennan

- Last updated on GMT

Data quality issues are the chief concern
Data quality issues are the chief concern

Related tags Chromatography High performance liquid chromatography

Cited with data quality issues, Italian API manufacturer Trifarma has until July 24 to respond to a litany of requests from the US FDA.

Specifically, the warning letter​ issued earlier this month calls Trifarma out for failing to retain complete raw data from testing performed to ensure the quality of its APIs. The firm went so far as to delete all electronic raw data supporting its high performance liquid chromatography (HPLC) testing of all API products released to the US. In addition, the Milan-based company failed to retain basic chromatographic information such as injection sequence, instrument method or integration method for the tests. 

The FDA inspection of the manufacturing site in January also found that the company’s HPLC and gas chromatograph (GC) computer software 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. 

Your firm’s lack of data control causes us to question the reliability of your data​,” the FDA says. “Your firm did not have proper controls in place to prevent the unauthorized manipulation of your laboratory’s raw electronic data.  Specifically, your laboratory systems did not have access controls to prevent deletion or alteration of raw data. The inspection noted that all laboratory employees were granted full privileges to the computer systems​.”

The company’s laboratory management was also unaware of, and therefore did not follow, the written procedure detailing the review of analytical data.


A response to a Form 483 on the issue of data reliability said the company would have a backup system in place by Q3 of this year, and until then the company would provisionally store data on each computer. However, the FDA says that Trifarma does not address the backup of the injection sequence, the instrument method or audit trails, and also failed to ensure that electronic files are not deleted prematurely from local computers.

In addition, Trifarma failed to document any training of production employees on the production operations they perform, which for the FDA means “there is a lack of assurance that your employees can reliably execute their API manufacturing responsibilities​.”

For its response, the FDA requests “information regarding system-wide changes, revised procedures, and appropriate retraining of employees that will be implemented immediately to ensure retention of complete electronic raw data for all laboratory instrumentation and equipment​.”

The agency also requests a corrective action plan to prevent the deletion and alteration of electronic data. In addition, the FDA seeks a more detailed description of the company’s new archival process.

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