# FDA 483 - Daewoo Pharmaceutical Co., Ltd. - January 15, 2025

Source: https://www.keypedia.com/records/483/daewoo-pharmaceutical-co-ltd/d9c7879d-9699-4ef4-a6a9-9ac2ff7a35a0

> FDA 483 for Daewoo Pharmaceutical Co., Ltd. on January 15, 2025. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daewoo Pharmaceutical Co., Ltd.
- Inspection Date: 2025-01-15
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: **FDA 483 Summary for Executives: Daewoo Pharmaceutical Co., Ltd.**

**Inspection Overview:**
- **Company:** Daewoo Pharmaceutical Co., Ltd.
- **Location:** Saha, Busan, Korea
- **Inspection Dates:** January 6-15, 2025
- **Facility Type:** Contract Manufacturing Organization

**Key Violations:**
1. **Aseptic Processing Issues:**
   - Inadequate validation of sterilization processes, particularly smoke studies lacking simulation of interventions during aseptic manufacturing.
   - Non-uniform airflow due to gaps between HEPA filters, causing turbulence.
   - Insufficient media fills that do not adequately simulate routine production risks.
   - Lack of documentation and tracking of interventions during production.

2. **Aseptic Personnel Qualification:**
   - Operators participate in aseptic filling without prior media fill participation.
   - Incomplete procedures for gowning qualification and monitoring.
   - No risk assessment for personnel monitoring locations.

3. **Validation Study Deficiencies:**
   - Inadequate placement of biological indicators in sterilization validation studies.
   - Lack of detailed protocols for validation study execution.

**Regulatory Framework:**
The inspection was conducted under the regulatory framework governing Good Manufacturing Practices (GMP) for pharmaceuticals, focusing on ensuring product sterility and safety.

**Required Actions:**
- Implement comprehensive corrective actions to address the identified deficiencies.
- Enhance validation processes for aseptic operations and personnel qualifications.
- Establish robust procedures to ensure consistent and effective sterilization practices.
- Submit detailed corrective action plans to the FDA for review and approval.

The FDA expects Daewoo Pharmaceutical Co., Ltd. to take immediate steps to rectify these issues to ensure compliance with regulatory standards and safeguard product quality.

## Related Documents

- [483 - 2025-01-15](https://www.keypedia.com/records/483/daewoo-pharmaceutical-co-ltd/5c980705-2cbc-4daf-8b84-a1568622c950)
- [483 - 2025-01-15](https://www.keypedia.com/records/483/daewoo-pharmaceutical-co-ltd/8e464b2d-3dde-4fe4-b699-ac762e20ab1e)
- [WARNING_LETTER - 2025-01-15](https://www.keypedia.com/records/warning_letter/daewoo-pharmaceutical-co-ltd/b2da3b8e-d146-4e6e-9151-ac586707c077)

## Related Officers

- [Drug National Expert](https://www.keypedia.com/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)
- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)

Company: https://www.keypedia.com/companies/daewoo-pharmaceutical-co-ltd/440e3629-5661-4fac-bc0e-71ae7f78f63b

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa