FDA Warns Italian Drugmaker for GMP Violations
The US Food and Drug Administration (FDA) earlier this month warned Italian ophthalmic drugmaker Tubilux Pharma for manufacturing and testing issues at its facility in Rome, Italy.
The warning letter follows a nine-day inspection of Tubilux's production site that revealed potential contamination hazards, as well as issues with the company's particulate matter and sterility testing practices.
According to FDA, smoke studies to test airflow in the facility conducted in September 2015, as well as follow up studies from December 2016, revealed turbulent airflow in multiple areas along the facility's aseptic filling line.
"This turbulent airflow poses a significant contamination hazard to your product," FDA says, noting that the company did not establish that unidirectional airflow exists in the area where caps are fitted to products containers.
FDA also says its investigator observed employees performing "significant routine and non-routine interventions" during production of a specific lot of drugs that could pose a "significant hazard" to the company's aseptic processing operations.
As such, FDA is asking Tubilux to identify potential contamination hazards at the facility, including its layout, personnel and material flow, as well as the protection of its ISO 5 cleanroom.
In a separate citation, FDA says the company failed to test products for particulates before releasing them.
"Our investigator observed repeated instances of high particle count alarms during production," the agency says.
While FDA says the company has acknowledged the need for particulate testing, it did not provide a plan for implementing such tests.
Additionally, FDA says that one of the steps in the company's sterility testing procedures could kill or injure the microorganisms it is testing for, compromising the tests' validity.