Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta
Form 483 issued December 17, 2025 · Macau, Macau
- Inspection
- Dec 15 – Dec 17, 2025
- Investigators
- Andrew Le· Lillian S. Wu
- Observations
- 8
- Pages
- 7
- FEI number
- 3011219786
In short: On December 17, 2025, FDA issued a Form 483 with 8 observations to Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta in Macau, Macau (FEI 3011219786) after an inspection that ran Dec 15 – Dec 17, 2025. The investigators were Andrew Le and Lillian S. Wu. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Laboratory controls and materials account for 5 of 8 observations.
Most cited: 21 CFR 211.84 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The identity of each component of a ding product is not verified by conducting at least…
- 03
Each component is not tested for conformity with all appropriate written specifications for purity, strength…
- 04
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
This inspection in context
Andrew Le
10 documents · 2022–2025
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmMacau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, materials and production. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta?
Andrew Le and Lillian S. Wu are named on this Form 483, for the inspection of Dec 15 – Dec 17, 2025. Each investigator has a profile showing what they cite most.
When was Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta inspected by FDA?
The inspection ran Dec 15 – Dec 17, 2025, and the Form 483 is dated December 17, 2025.
How do I get the full Form 483 for Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.