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

Source: https://www.keypedia.com/records/483/macau-union-pharmaceutical-limited/460af85c-94ea-4340-b5be-b7779dfbbc7f

> 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: Baltimore District Office
- Summary: During an inspection conducted from December 15 to December 17, 2025, the U.S. Food and Drug Administration (FDA) identified significant quality control deficiencies at Macau-Union Pharmaceutical Limited, a drug manufacturer located in Macau. The inspection revealed that the firm failed to meet essential manufacturing standards for over-the-counter products intended for the United States market. Key violations included the release of drug products without performing laboratory tests to confirm their strength, identity, or freedom from microbial contamination. Additionally, the company did not verify the identity of raw ingredients or ensure they met purity and quality specifications, often relying on unverified supplier reports that did not follow standard pharmacopeial methods. The facility also failed to validate its manufacturing processes and cleaning procedures for shared equipment, creating a risk of product inconsistency and cross-contamination. Furthermore, the firm lacked a stability testing program to ensure products remain effective throughout their shelf life and did not maintain complete records for product labeling or annual inspections of reserve samples. To address these findings, Macau-Union Pharmaceutical Limited must submit a formal response to the FDA detailing their corrective action plan and any objections to the observations to ensure future compliance with safety and quality regulations.

## 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/e726a1d9-6118-43f9-aaca-fb3f391c1734)

## Related Officers

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

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

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