FDA EIR - CMIC CMO USA Corporation - May 04, 2021

An FDA pre-approval inspection (PAI) of CMIC CMO USA Corporation in Cranbury, NJ, was conducted from April 27 to May 4, 2021. The inspection, which evaluated previous corrective actions and a PAI for a New Drug Application (NDA), resulted in two observations detailed on Form FDA 483.

First, the company was cited for not establishing appropriate time limits for each production phase to ensure drug product quality, specifically lacking in-process hold-time parameters for tablet manufacturing. This omission raises concerns about potential powder blend separation that could affect tablet uniformity, violating 21 CFR 211.111.

Second, the electronic system used to schedule and track production and laboratory equipment maintenance and calibration was deemed ineffective. It failed to reliably store or retrieve historical data, thus not meeting regulatory requirements for trustworthy electronic records as per 21 CFR 211.67(c).

In response, CMIC CMO USA Corporation's CEO committed to providing a written reply to the FDA Form 483 within 15 business days. Management acknowledged the need for hold time data and indicated plans to re-evaluate critical control points and assess new equipment calibration programs. A commitment letter was also submitted, dedicating a new tablet press to a specific product until full cleaning validations are completed post-NDA approval. The inspection concluded with a recommendation for NDA approval, pending CDER review.