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The agency cited the Italian company for aseptic processing failures.
FDA sent a warning letter, dated July 6, 2017, to Tubilux Pharma S.p.A. after an inspection of the company’s Pomezia, Rome facility found CGMP violations in regard to aseptic manufacturing. The inspection was conducted from Dec. 1–9, 2016.
In the letter, FDA details aseptic manufacturing deficiencies that include improper equipment use, insufficient laboratory controls, and problems with the company’s sterility assurance program. Specifically, inspectors found turbulent airflow in smoke studies conducted in September 2015, which FDA said posed a significant contamination hazard. The company responded to FDA with additional smoke studies conducted in December of 2016. The agency stated in the letter that those additional smoke studies also showed turbulent airflow.
“You have not established that unidirectional airflow exists at the station where the cap is applied to the container,” the agency stated. FDA asked the company to identify all contamination hazards, complete a formal risk assessment, and prepare a corrective action and preventive action plan.
Investigators also found a lack of scientifically sound laboratory controls. “You do not require your (b)(4) products to be tested for particulates prior to release. Notably, our investigator observed repeated instances of high particle count alarms during production of (b)(4) lot (b)(4) on December 2, 2016,” the letter stated. The agency is asking the company to provide an implementation plan for testing particulate matter in product that includes revised specifications and written procedures for in-process inspection of units for visible particulates.
Other problems found included improper stability testing and recurring instances of clogging during batch manufacture.