The plant in Bloomington received a Form 483 with five observations in May, but Catalent says a second US FDA inspection shows issues have been resolved.

The US Food and Drug Administration (FDA) recently published a Form 483 it issued to Catalent’s biomanufacturing facility in Bloomington, Indiana following an inspection in April and May this year.

The Agency made five observations at the 875,000ft2 production and fill/finish facility, which the contract development and manufacturing organization (CDMO) gained as part of its $950 million (€810 million) acquisition of Cook Pharmica last year.

The Catalent plant iconcerned s located in Bloomington, Indiana. Image: iStock/wellesenterprises

In the heavily redacted April/May inspection report, the FDA observed “an unacceptably high number of mold recoveries used in the classified rooms” used for the manufacture of an undisclosed bulk drug substance.

Other observations included issues with written procedures to prevent contamination, a lack of quality oversight in the review of records and procedures followed in drug substance manufacture, inadequate procedures in place to avoid deviations from reoccurring, and insufficient controls to prevent unauthorized changes to data stored on the firm’s HPLC and GC computer system.

Second inspection

But these concerns have all since been remediated, a Catalent spokesperson told BioProcess Insider.

“All observations identified during the FDA pre-approval inspection in April/May 2018 have been addressed, and corrective actions have been implemented,” we were told.

“Most of the items noted were self-identified by Catalent and a corrective and preventive action plan (CAPA) was in place prior to the inspection.”

Business was not impacted as a result of the findings from this inspection, and furthermore a successful follow-up FDA audit has already taken place at the plant.

“Catalent remains confident in the robustness of the quality systems and inspection history at our Bloomington, Indiana site, as evidenced by a more recent FDA inspection with zero observations.”