Brio Pharmaceuticals, Inc.
Form 483 issued February 27, 2026 · Houston, Texas
- Inspection
- Feb 23 – Feb 27, 2026
- Investigator
- Timothy H. Vo
- Observations
- 2
- Pages
- 3
- FEI number
- 1628196
In short: On February 27, 2026, FDA issued a Form 483 with 2 observations to Brio Pharmaceuticals, Inc. in Houston, Texas (FEI 1628196) after an inspection that ran Feb 23 – Feb 27, 2026. The investigator was Timothy H. Vo. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.166(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The written stability testing…
This inspection in context
Timothy H. Vo
9 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Texas.
The firmBrio Pharmaceuticals, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Brio Pharmaceuticals, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Brio Pharmaceuticals, Inc.?
Timothy H. Vo is named on this Form 483, for the inspection of Feb 23 – Feb 27, 2026. Each investigator has a profile showing what they cite most.
When was Brio Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Feb 23 – Feb 27, 2026, and the Form 483 is dated February 27, 2026.
How do I get the full Form 483 for Brio Pharmaceuticals, 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.