Italian API Manufacturer Receives FDA Warning Letter for Data Integrity Issues

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Italian API Manufacturer Receives FDA Warning Letter for Data Integrity Issues
On July 7th the US FDA issued a Warning Letter to Trifarma S.p.A. for violating Good Manufacturing Standards at their facility in Rozzano, Italy. The company produces APIs and had been inspected early this year.

Read more about this Warning Letter here

http://www.gmp-compliance.org/enews_4400_Italian%20API%20Manufacturer%20Receives%20FDA%20Warning%20Letter%20for%20Data%20Integrity%20Issues_8509,S-WKS_n.html

On July 7th the US FDA issued a Warning Letter to Trifarma S.p.A. for violating Good Manufacturing Standards at their facility in Rozzano, Italy. The company produces APIs and had been inspected early this year. As a result of the inspection and the response of the company to the GMP findings the FDA decided to issue a Warning Letter.

While so far mainly Indian Manufacturers have been blamed by FDA and EU Inspectors for data integrity issues, now also an European API manufacturer has been cited for that problem. According to the Warning Letter the…

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