FDA EIR - Catalent Pharma Solutions, LLC - August 02, 2021

An FDA Pre-Approval Inspection (PAI) was conducted at Catalent Pharma Solutions LLC in Winchester, KY, on August 2, 2021. This inspection, carried out under CPGM 7346.832, specifically evaluated the company's new packaging operations for NDA 05805 Supplement 014, "Oracea" (Doxycycline Monohydrate) CR Capsules.

The main issues identified during the inspection related to the validation of equipment and data integrity. It was noted that the firm used a limited number of data points to establish the operational range for the induction sealer in the batch record, raising concerns about the scientific justification for the proposed settings. Additionally, some equipment, such as the (b) (4) and (b) (4), had not completed qualification. The audit trail review also highlighted that the induction sealer and retorquer lacked comprehensive audit trail capabilities or individual user sign-on.

In response, Catalent's management committed to tightening the induction sealer's range on the master batch record and performing additional performance qualification to substantiate the revised range before commencing process performance qualification batches. The FDA confirmed that it would recommend approval of the facility for packaging operations related to this application, pending resolution of these observations.