Amit G. Shah, MD
Form 483 issued April 2, 2026
- Inspection
- Mar 30 – Apr 2, 2026
- Investigators
- Anthony Grace· Peyton L. Sloan
- Observations
- 2
- Pages
- 3
- FEI number
- 3043422813
In short: On April 2, 2026, FDA issued a Form 483 with 2 observations to Amit G. Shah, MD (FEI 3043422813) after an inspection that ran Mar 30 – Apr 2, 2026. The investigators were Anthony Grace and Peyton L. Sloan. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.64 (investigator reports).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.64 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to report serious adverse events…
- 02
Failure to report non-serious adverse events to the sponsor in accordance with the study…
This inspection in context
Anthony Grace
2 documents · 2024–2026
Cites 312.64 (investigator reports) more than any other section. Most of their documents are for sites in Canada.
The firmAmit G. Shah, MD history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.64
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amit G. Shah, MD?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.64 (investigator reports). The opening words of each observation are shown on this page.
Who inspected Amit G. Shah, MD?
Anthony Grace and Peyton L. Sloan are named on this Form 483, for the inspection of Mar 30 – Apr 2, 2026. Each investigator has a profile showing what they cite most.
When was Amit G. Shah, MD inspected by FDA?
The inspection ran Mar 30 – Apr 2, 2026, and the Form 483 is dated April 2, 2026.
How do I get the full Form 483 for Amit G. Shah, MD?
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.