FDA Investigator

Amy W Yan-Mai

Latest inspection on record: Montvale, United States, July 2026 · records back to 2021

Biologics

FDA inspection record · Last updated August 15, 2026

Overview

  • 71 inspections across 64 sites are on record.
  • 66 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2026-07-10.

At a glance

Inspections

71

Sites

64

Observations

66

Career since

Nov 2021

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
Vitalant10 Jul 2026Biologics
Shore Institute For Reproductive Medicine, P.C.22 Jun 2026Biologics
Statline (division of MTF Biologics)4 Jun 2026Biologics
RWJ Barnabas Health-Newark Beth Israel Medical Center - Blood Bank22 Apr 2026Biologics
New York Blood Center Inc2 Apr 2026Biologics

Sites inspected

VitalantMontvale, United States1 insp.
Statline (division of MTF Biologics)Edison, United States1 insp.
New York Blood Center IncFreehold, United States1 insp.

Co-investigators

Investigators who share inspections with this person.

Amy W Yan Mai10 shared
Amy Kim6 shared

Full investigator report

Get the verbatim findings behind Amy W Yan-Mai's 66 observations

Source 483 PDFs, verbatim observations, and how each site responded, so your team knows what they cite before they arrive.

  • New inspections and Form 483s, mapped to the CFR citation
  • Warning letter outcomes, and the citation patterns they repeat
  • Their co-investigators, so no surprises about who shows up on site