FDANews
The QMN Weekly Bulletin

FDA Hits Tubilux Pharma for Contamination Risks, Particulate Testing

July 21, 2017

Drugmaker Tubilux Pharma manufactured products in conditions that risked contamination and failed to properly test its products before release, according to the FDA.

The agency issued a warning letter following a December 2016 inspection of its facility in Rome, Italy. Investigators found documentation of turbulent airflow in the company’s smoke studies conducted in the area where the company manufactures at least two products, posing a major contamination hazard, the agency said. The investigators also noted equipment operators reaching directly over equipment while loading sterile container-closure components.

The company also failed to require product testing for particulates prior to release even though investigators observed several high-particle count alarms during the production of a product lot. The company amended its change control document to incorporate particle testing into the production process, but the document lacked specifics as to how it would implement the testing.

In addition, the company’s decontamination process potentially kills organisms that sterility testing would otherwise detect, casting doubt on the reliability of the test results, the agency said.

The FDA called on Tubilux to identify all contamination hazards associated with the company’s equipment, aseptic processes and facilities and called for a formal risk assessment and a comprehensive CAPA plan. It also calls on the firm to submit a full implementation plan for its particulate matter testing procedure, as well as summarize all clogging incidents since December 2015 and provide a CAPA addressing its problems with sterility testing.