The FDA has slapped an Italian sterile manufacturer with a warning letter after an inspection raised questions about the contamination hazards tied to highly manual processes on its filling lines, then found its sterility testing processes lacked the rigor needed to assure safe products are being shipped to the U.S.
The warning letter was issued this month to Rome-based Tubilux Pharma and a highly redacted copy posted Tuesday to the FDA site.
In it, the FDA first criticized the sterile drug maker for turbulent airflow over one of its aseptic processing lines. In addition, it noted that workers are having to reach over bowls while loading sterile container closure components to overcome poor design in the facility. Both of those factors pose “a significant contamination hazard” to Tubilux products, the letter reads.
On top of that, the FDA said that Tubilux was not testing for particulate in finished products despite the fact that investigators observed repeated instances of high particle count alarms during production of some products when they visited in December 2016.
The FDA also said there was an issue with an impurity clogging a piece of equipment that repeatedly affected batch manufacturing.
Aseptic filling can be tricky and companies large and small struggle with it. Teva in May said it would lay off 500 employees at its sterile manufacturing site in Godollo, Hungary, and sell or close the plant by next year after struggling to resolve issues laid out by the FDA in a warning letter last year.
Earlier this year, the FDA sent a hard-hitting letter to management of B. Braun because of what it called persistent problems at a plant in California that makes parenteral drugs.