UBI Pharma Inc.
Form 483 issued June 20, 2019 · Hukou, Taiwan
- Investigator
- David J. Gomes
- Observations
- 3
- Pages
- 2
- FEI number
- 3004713402
In short: On June 20, 2019, FDA issued a Form 483 with 3 observations to UBI Pharma Inc. in Hukou, Hsinchu (FEI 3004713402). The investigator was David J. Gomes. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory raw data records are not complete to include final…
- 02
Laboratory records did not include final summary report of test results summary data correlated with laboratory…
- 03
Executed batch records did not include detailed explanation 6 of each deviation during manufacturing process. For…
This inspection in context
David J. Gomes
3 documents · 2017–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Italy.
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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at UBI Pharma Inc.?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected UBI Pharma Inc.?
David J. Gomes is named on this Form 483. Each investigator has a profile showing what they cite most.
When was UBI Pharma Inc. inspected by FDA?
This Form 483 is dated June 20, 2019.
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.