UBI Pharma Inc.
FDA inspection history across 2 sites, 2019 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Hukou, Taiwan.
- 2025One Form 483, at Hsinchu, Taiwan.
- 2025The longest 483 on file: 5 observations over 9 pages at Hsinchu, Taiwan.
Cited most
Across all UBI Pharma observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.194Laboratory records2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.188Batch production and control records1
The complete UBI Pharma 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
Hsinchu, Taiwan
One Form 483 · 2025 · 5 observations
Latest: Form 483, Oct 14, 2025 →Hukou, Taiwan
One Form 483 · 2019
Latest: Form 483, Jun 20, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-10-14 | 483 Form 483 | Hsinchu, Taiwan | 5 | $99 |
| 2019-06-20 | 483 Form 483 | Hukou, Taiwan | — | $99 |
Investigators on these documents
FEI number 3004713402 · most recent document Oct 14, 2025
About UBI Pharma Inc.
How many FDA Form 483s has UBI Pharma Inc. received?
FDA Intel has 2 Form 483s on file for UBI Pharma Inc.; the most recent is dated Oct 14, 2025.
When was UBI Pharma Inc. last inspected by FDA?
The most recent FDA inspection document on file for UBI Pharma Inc. is a Form 483 dated Oct 14, 2025, for the site in Hsinchu, Taiwan.
What did FDA cite at UBI Pharma Inc.?
The regulations cited most in the observations on file for UBI Pharma Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.194 (Laboratory records), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.