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

Source: https://www.keypedia.com/records/483/samsung-bioepis-co-ltd/1d713bc3-1984-44d9-9386-a60c23c90e79

> FDA 483 for Samsung Bioepis Co., Ltd. on November 22, 2024. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samsung Bioepis Co., Ltd.
- Inspection Date: 2024-11-22
- Product Type: Drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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:**

## Related Documents

- [483 - 2023-09-15](https://www.keypedia.com/records/483/samsung-bioepis-co-ltd/315a6a1d-3e37-4577-b209-cb07acedaefb)
- [483 - 2023-09-15](https://www.keypedia.com/records/483/samsung-bioepis-co-ltd/3ea42fc3-70e9-45b2-a36d-d7f2c0e69b72)
- [483 - 2024-11-22](https://www.keypedia.com/records/483/samsung-bioepis-co-ltd/b0e2d6ae-39d1-43b9-a6ff-b61df2c51749)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.keypedia.com/companies/samsung-bioepis-co-ltd/6473332d-84de-441c-82fe-4034d7383d5e

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8