# FDA 483 - Fulijaya Manufacturing Sdn. Bhd - July 18, 2025

Source: https://www.globalkeysolutions.net/records/483/fulijaya-manufacturing-sdn-bhd/29b3fbfd-ff33-4ca8-97c4-c73b93a730b5

> FDA 483 for Fulijaya Manufacturing Sdn. Bhd on July 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fulijaya Manufacturing Sdn. Bhd
- Inspection Date: 2025-07-18
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Fulijaya Manufacturing SDN. BHD. in Kulim, Kedah, Malaysia, was inspected regarding its drug product manufacturing. The inspection revealed significant deficiencies across its quality system, including inadequate stability programs, insufficient testing of raw materials and finished products for specifications and microorganisms, lack of validated cleaning procedures, and incomplete documentation for quality control and batch records. These issues indicate a systemic failure to ensure drug product quality and safety.

## Related Documents

- [WARNING_LETTER - 2025-07-18](https://www.globalkeysolutions.net/records/warning_letter/fulijaya-manufacturing-sdn-bhd/9f6a7af6-80c7-45a3-9d3d-2af25df91ed5)

## Related Officers

- [Carolina D. Vasquez](https://www.globalkeysolutions.net/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)

Company: https://www.globalkeysolutions.net/companies/fulijaya-manufacturing-sdn-bhd/22d97d2b-36a8-4942-af11-c5837d7c5cd5

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