Catalent’s Belgium operations get a second FDA scolding within 1-year span

Catalent’s Belgium manufacturing operations were slapped with a second Form 483 by the FDA inside of a 12-month span after inspectors uncovered a host of equipment problems during an August inspection.

In the wake of an FDA inspection conducted between August 10 and August 18 at the Brussels plant, the company received a total of nine observations. Inspectors highlighted problems with air filters in aseptic areas, deficient changes to the HVAC system, and other equipment-related issues.

Additionally, inspectors found that backup data was not being verified, and the facility lacked procedures for “receiving and control of customer designs."

“Catalent’s Brussels facility is implementing the improvements it committed to execute following the FDA’s inspection,” a Catalent spokesperson told Fierce Pharma in an email. “The company takes all observations very seriously and immediately works to address the FDA’s findings.”

This Form 483 comes after an inspection last October uncovered similar issues at the company’s syringe filling plant in Brussels. Those observations focused on the site failing to thoroughly investigate batch failures or discrepancies, problems dealing with high-efficiency particulate absorbing (HEPA) filter failures, and more. The problems last year contributed to supply difficulties for Novo Nordisk's obesity launch Wegovy.

Meanwhile, the latest FDA warning for Catalent comes fast on the heels of the CDMO’s Bloomington, Indiana, facility receiving a Form 483 that cited particles like black specks were found in vials. That issue contributed to an early delay for Moderna's updated COVID-19 booster rollout, The Washington Post reported.