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.

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.