Covidien Warned for Imaging Agent Production Operations

Covidien did not establish certain manufacturing control procedures for its Ultra-TechneKow DTE generator kit, which may have led to customer complaints of elevated levels of the element molybdenum-99 being detected in the imaging agent produced by the generator, according to an FDA warning letter.

The Ultra-TechneKow DTE generator (technetium-99) is a closed system that produces radioisotope technetium-99, an imaging agent with multiple applications. Technetium-99 is produced during the decay of molybdenum-99.

“Appropriate controls for [redacted] backwashing, column assembly and column activation were not established, validated and monitored to assure that the molybdenum adsorbs and remains adsorbed to the column,” the letter said. “Failure of the molybdenum to remain adsorbed to the column can lead to the molybdenum breakthrough defect.”

The warning letter resulted from a March inspection at the firm’s Maryland Heights, MO, facility. The inspection was prompted by complaints about the presence of excessive levels of the parent isotope molybdenum-99, which were detected after the imaging agent was generated from the kit, the company said.

SOURCE: FDANEWS