FDA 483 - Celltrion Inc. - July 17, 2018

This FDA Form 483 details multiple observations from an inspection. The facility lacks written procedures for production and process controls, specifically regarding glass vial breakage during drug product filling. For example, batch (b)(4) on April 5, 2018, documented two broken vials, but the record lacked details on the number of vials removed or procedures to prevent compromised vials from proceeding. Similarly, on March 25, 2018, broken vials were found at the outlet of the (b)(4) zone for batch (b)(4), but filling continued without adequate documentation to ensure compromised vials were removed.

Employees performing 100% visual inspection of finished (b)(4) drug product lack adequate training. Qualification vials for glass particles are positioned on the (b)(4) of the (b)(4) rather than (b)(4) the (b)(4) at the (b)(4) of the vial. Training photographs for this defect are unclear. There is no procedure to address employees who repeatedly fail to identify specific defects during qualification runs, as observed with Operator (b)(4) in January 2018.

Routine checking of automatic equipment is not performed according to written procedures. A (b)(4) sensor used to reject uncapped vials is not challenge tested prior to each batch, and its setting is not documented in batch records.

Procedures for instrument calibration are deficient. Routine temperature monitoring gauges for