Tubilux Pharma sterile plant in Rome spanked in FDA warning letter

Drug vials
The FDA has cited a Tubilux Pharma sterile manufacturing facility in Rome after inspectors raised questions about contamination hazards.

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.


Veeva 2020 Unified Clinical Operations Survey

We believe you have the knowledge and expertise to make this year's Veeva 2020 Clinical Operations Report even more robust and insightful than the last. Please take a moment to share your opinion in this 10-minute survey. All qualified respondents will be entered to win a $500 Amazon gift card.

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.

RELATED: Teva laying off 500 at struggling sterile injectables plant in Hungary

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.

Suggested Articles

Fujifilm says it is prepared to ramp up production of Avigan for any country that wants to try it as a potential treatment for COVID-19.

As flights from China contract and prices double, the logistics of getting products out of China is a major challenge. 

A group of drugmakers and others say some federal policies to fight COVID-19 are it making more expensive and harder to get some drugs.