FDA EIR - CorePharma, LLC - December 13, 2019

An FDA pre-approval inspection of CorePharma, LLC, located in Middlesex, NJ, was conducted from December 9-13, 2019. This inspection was performed under the New Drug Evaluation Compliance Program 7346.832 to support an Abbreviated New Drug Application (ANDA) and ensure adherence to current Good Manufacturing Practices (CGMP) for drug manufacturing.

The inspection concluded without any formal FDA Form 483 observations being issued. However, three verbal discussion items were raised with CorePharma's management. Firstly, the firm's visual inspection procedures for product defects lacked clear explanations and visual representations, which the company rectified by providing an updated procedure with illustrative images during the inspection. Secondly, the company had not established scientific data to support blend hold times during its manufacturing process. CorePharma's management committed to conducting a blend hold study to validate these critical hold times. Lastly, a discrepancy was noted between an analytical test method's specified retention time and actual observed chromatograms, which was resolved by updating the test method after communication with their partner. The firm was also actively working on enabling comprehensive audit trail functionality for its tablet press.

Overall, the facility demonstrated satisfactory compliance, and an approval recommendation was provided for the ANDA application, based on the prompt and agreeable responses from management to address the identified discussion points.