# FDA 483 - Macau-Union Pharmaceutical Limited - December 17, 2025

Source: https://www.keypedia.com/records/483/macau-union-pharmaceutical-limited/e726a1d9-6118-43f9-aaca-fb3f391c1734

> FDA 483 for Macau-Union Pharmaceutical Limited on December 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Macau-Union Pharmaceutical Limited
- Inspection Date: 2025-12-17
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Macau-Union Pharmaceutical Limited, a drug manufacturer in Macau, was cited with eight observations during an FDA inspection. The firm demonstrated significant deficiencies across its quality control system, including a lack of finished product testing, component identity and quality testing, process validation, and stability testing. These issues indicate a systemic failure to ensure the quality, purity, and strength of drug products intended for the U.S. market.

## Related Documents

- [WARNING_LETTER - 2025-12-17](https://www.keypedia.com/records/warning_letter/macau-union-pharmaceutical-limited/38965a27-9b3b-48df-b9cb-2508f39ab7cb)
- [483 - 2025-12-17](https://www.keypedia.com/records/483/macau-union-pharmaceutical-limited/460af85c-94ea-4340-b5be-b7779dfbbc7f)

## Related Officers

- [Regulatory Affairs Specialist](https://www.keypedia.com/people/andrew-le/573464c0-de29-4f64-ab33-62543b7fe719)
- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)

Company: https://www.keypedia.com/companies/macau-union-pharmaceutical-limited/8d630c2e-bc66-456f-80ff-9e13617bda19

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