FDA Hits UCB Facility in Switzerland with Form 483, Cites Quality Control and Records Issues


UCB Farchim, a unit of Belgian drugmaker UCB, has been hit with a Form 483 from the FDA, with the observations mainly centered around quality control and record-keeping.

The four-observation regulatory slap follows an inspection of the UCB Farchim facility between June 26 and July 4 in Bulle, Switzerland.

The agency’s inspector found that the company’s quality control operations were “deficient,” according to the filing posted on the FDA’s website.

“I observed multiple instances of interrupted injections, which I requested to be verified (brought back), for further evaluation,” the inspector wrote. “In addition, test runs appeared to have been manually interrupted via a ‘user abort’ function, which, like ‘Data Incomplete’ and ‘Data Missing’ interruptions, your firm does not document and/or trend.”

The facility’s quality control unit was also cited for “lacking adequate control” over certain electronic records, including batch control records.

Further, the FDA cited issues with the company’s analytical method transfers for an unnamed active pharmaceutical ingredient and with procedures that detail the handling of components.

UCB has weathered a series of manufacturing-related hurdles over the last few years.

Before this, quality control problems at UCB’s facility in Braine-l’Alleud, Belgium, resulted in a Form 483 being issued by the FDA in May.

And, in 2022, the company’s highly anticipated psoriasis drug bimekizumab suffered an FDA rejection because the agency wasn’t able to inspect a plant in a timely manner. The drug has since won approval.

Source : Fiercepharma