The FDA has caught an Italian drugmaker apparently manipulating testing data as it reported only passing tests even though original reports indicated out-of-specification results for things like particulate in sterile drugs.
The FDA issued a warning letter to Milan-based Facta Farmaceutici for a plant in San Nicolo a Tordino, Teramo. The FDA had inspected the plant in January 2016, but didn't issue its letter until Jan. 13, 2017, which it posted this week.
The agency spanked the plant for storing the original data in an “unofficial” and uncontrolled electronic spreadsheet on a shared computer network drive. An analyst told the FDA inspector that the data was transcribed later to an “official” form. But of course, the FDA wants to know about failed tests to determine if plants are investigating and dealing with the root cause of OSS readings.
On top of that, the FDA said the inspector saw employees shredding records, including HPLC documents and a partially completed OOS form. “Uncontrolled destruction of CGMP records also raises concerns,” about the effectiveness of its the facility's quality unit and the integrity and accuracy of its CGMP records, the FDA said.
Facta Farmaceutici was given a substantial load of homework, including interviewing employees, past and present, about the recorded lapses and providing the FDA with a complete report on how sterile drugs it has shipped to the U.S. may have been affected by the problems uncovered during the inspection.
The FDA questioned another drugmaker recently about employees destroying documents after video footage showed workers shredding what appeared to be manufacturing and packaging documents at 1 a.m., four days before an FDA inspection at an Hetero Labs facility in Jadcherla, India.