FDA Investigator

Amy W Yan-Mai

Latest inspection on record: Edison, United States, June 2026 · records back to 2021

Biologics

FDA inspection record · Last updated July 12, 2026

Overview

  • 69 inspections across 62 sites are on record.
  • 66 Form 483 observations are attributed to this investigator.
  • Most recent recorded activity is 2026-06-04.

At a glance

Inspections

69

Sites

62

Observations

66

Career since

Nov 2021

Recent inspections

Most recent inspections in the published record.

SiteDateCategoryForm 483
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
Institute for Reproductive Medicine and Science at Saint Barnabas, P.A.13 Mar 2026Biologics
East Coast Infertility and IVF PC18 Feb 2026Biologics

Sites inspected

Statline (division of MTF Biologics)Edison, United States1 insp.
RWJ Barnabas Health-Newark Beth Israel Medical Center - Blood BankNewark, United States1 insp.
New York Blood Center IncFreehold, United States1 insp.
Institute for Reproductive Medicine and Science at Saint Barnabas, P.A.Livingston, United States1 insp.
East Coast Infertility and IVF PCShrewsbury, 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

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