FDA 483 - Samsung Bioepis Co., Ltd. - November 22, 2024

The FDA inspected Samsung Bioepis Co. Ltd., a testing laboratory in Incheon, Korea, from November 20-22, 2024. The inspection revealed two observations regarding their quality system.

**Observation 1: Inadequate Complaint Handling Procedures**

The firm's complaint handling procedure (SOP-GxP-CML-00944 Version 13.0) lacks a timeline for initial assessment of market complaints. Several instances demonstrated this deficiency:

* **Complaint PC-016468 (Particulate matter):** A High/Class 1 criticality complaint, requiring investigation within a specified timeframe, was not initially assessed until significantly after recording. The complaint was misclassified as Medium, and an investigation was not launched promptly. * **Complaint PC-017796 (Particulate matter):** Similar to the above, initial assessment was delayed for a High/Class 1 complaint. The investigation was closed, but the complaint remained open. * **Complaint PC-016044 (Particulate matter):** Initial assessment was delayed, and the complaint was classified as Medium without investigation. * **Complaint PC-017396 (Stopper disconnection):** This complaint was incorrectly recorded as particulate matter. The investigation lacked testing to confirm the particulate's nature, and no root cause was identified. * **Defective Device Complaints:**