Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta
FDA inspection history in Macau, Macau, 2025 to 2026
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2025–26One Form 483 and one warning letter, at Macau, Macau.
Cited most
Across all Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta observations on file
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.170Reserve samples1
The complete Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Macau, Macau
One Form 483 · 2025 · 8 observations
Latest: Form 483, Dec 17, 2025 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-05-29 | Warning letter Warning letter | — | — | $99 |
| 2025-12-17 | 483 Form 483 | Macau, Macau | 8 | $99 |
Investigators on these documents
FEI number 3011219786 · most recent document May 29, 2026
About Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta
How many FDA Form 483s has Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta received?
FDA Intel has 1 Form 483 on file for Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta; the most recent is dated Dec 17, 2025.
When was Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta last inspected by FDA?
The most recent FDA inspection document on file for Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta is a Form 483 dated Dec 17, 2025, for the site in Macau, Macau.
What did FDA cite at Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta?
The regulations cited most in the observations on file for Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta are 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 3 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.
Has Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Macau-Union Pharmaceutical Limited Rua Cinco Do Bairro Da Areia Preta; the most recent is dated May 29, 2026.