Vera Therapeutics, Inc. 2000 Sierra Point Pkwy STE 1200
Form 483 issued March 2, 2026 · Brisbane, California
- Inspection
- Feb 23 – Mar 2, 2026
- Investigator
- Cynthia J. Tsui
- Observations
- 2
- Pages
- 3
- FEI number
- 3037451774
In short: On March 2, 2026, FDA issued a Form 483 with 2 observations to Vera Therapeutics, Inc. 2000 Sierra Point Pkwy STE 1200 in Brisbane, California (FEI 3037451774) after an inspection that ran Feb 23 – Mar 2, 2026. The investigator was Cynthia J. Tsui. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.53 (selecting investigators and monitors).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.53(c)(1) (1×) · 312.50 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to obtain a complete investigator statement, form FDA-1572, before permitting an investigator to…
- 02
Failure to provide investigators with the information needed to conduct the study properly and ensure the…
This inspection in context
Cynthia J. Tsui
2 documents · 2024–2026
Cites 312.50 (general responsibilities of sponsors) more than any other section. Most of their documents are for sites in California.
The firmVera Therapeutics, Inc. 2000 Sierra Point Pkwy STE 1200 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.53(c)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vera Therapeutics, Inc. 2000 Sierra Point Pkwy STE 1200?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.53 (selecting investigators and monitors). The opening words of each observation are shown on this page.
Who inspected Vera Therapeutics, Inc. 2000 Sierra Point Pkwy STE 1200?
Cynthia J. Tsui is named on this Form 483, for the inspection of Feb 23 – Mar 2, 2026. Each investigator has a profile showing what they cite most.
When was Vera Therapeutics, Inc. 2000 Sierra Point Pkwy STE 1200 inspected by FDA?
The inspection ran Feb 23 – Mar 2, 2026, and the Form 483 is dated March 2, 2026.
How do I get the full Form 483 for Vera Therapeutics, Inc. 2000 Sierra Point Pkwy STE 1200?
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.