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

Source: https://www.keypedia.com/records/483/samsung-bioepis-co-ltd/b0e2d6ae-39d1-43b9-a6ff-b61df2c51749

> FDA 483 for Samsung Bioepis Co., Ltd. on November 22, 2024. Product: Biologics. 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: Biologics
- Summary: **FDA 483 Summary: Samsung Bioepis Co. Ltd.**

**Inspection Dates:** November 20-22, 2024  
**Location:** Incheon, South Korea  
**Facility Type:** Testing Laboratory  
**Executive Contact:** Kyungah Kim, Executive Vice President, Development Division Leader  

**Main Violations/Issues:**
1. **Complaint Handling Procedures:** The firm"s procedures for handling written and oral complaints related to drug products were inadequately defined and not consistently followed. Specific issues included:
   - Lack of timelines for initial assessments of market complaints.
   - Misclassification of complaint criticality and incomplete investigations.
   - Numerous complaints regarding particulate matter and device malfunctions were not thoroughly investigated or resolved.
   - Use of a Complaint Intake form that was not reviewed or approved by the quality department.

2. **Quality Unit Responsibilities:** The responsibilities and procedures for quality units were not documented or followed, particularly concerning the assessment and reporting of Biological Product Deviation Reports (BPDR) for distributed products with quality issues. The Quality Agreement did not clearly define roles for BPDR submission.

**Regulatory Framework:** The observations are based on FDA regulations that require comprehensive complaint handling and quality assurance processes to ensure product safety and efficacy.

**Required Actions:**
- Revise and implement complaint handling procedures to include clear timelines and criteria for assessments and investigations.
- Ensure all complaints are accurately classified and investigated, with root causes identified and documented.
- Review and approve all complaint-related documentation by the quality department.
- Define and document the roles and responsibilities for BPDR submission in the Quality Agreement.

These observations highlight critical areas for improvement to ensure compliance with FDA standards and enhance product quality management.

## 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/1d713bc3-1984-44d9-9386-a60c23c90e79)

## 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