UBI Pharma Inc.
Form 483 issued October 14, 2025 · Hsinchu, Taiwan
- Inspection
- Oct 6 – Oct 14, 2025
- Investigator
- Rajiv R. Srivastava
- Observations
- 5
- Pages
- 9
- FEI number
- 3004713402
In short: On October 14, 2025, FDA issued a Form 483 with 5 observations to UBI Pharma Inc. in Hsinchu, Taiwan (FEI 3004713402) after an inspection that ran Oct 6 – Oct 14, 2025. The investigator was Rajiv R. Srivastava. Most observations concern production and quality system.
At a glance
Production and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of ding produc ts is not of…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Procedures designed to prevent microbiological contamination of ding products purporting to be sterile are…
- 04
The responsibilities and procedures applicable to the quality control unit are not in wilting…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmUBI Pharma Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at UBI Pharma Inc.?
FDA listed 5 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected UBI Pharma Inc.?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Oct 6 – Oct 14, 2025. Each investigator has a profile showing what they cite most.
When was UBI Pharma Inc. inspected by FDA?
The inspection ran Oct 6 – Oct 14, 2025, and the Form 483 is dated October 14, 2025.
How do I get the full Form 483 for UBI Pharma Inc.?
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.