Atlas

FDA-Inspected Site

SURGENEX LLC

2 FDA inspections are on record for SURGENEX LLC in Scottsdale, United States.

483· Form 483 issued

Scottsdale, United States · Last updated July 11, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-03-29.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
22 Mar 2023 – 29 Mar 2023Biologics483View 483 →
5 Apr 2021 – 16 Apr 2021Biologics483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

29 Mar 2023
21 CFR 1271.220(c)

In-process HCT/Ps-control

Cited by Garrad R Poole, Kaarin M Slotte

29 Mar 2023
21 CFR 1271.220(c)

In-process HCT/Ps-control

Cited by Garrad R Poole, Kaarin M Slotte

29 Mar 2023
21 CFR 1271.220(c)

In-process HCT/Ps-control

Cited by Garrad R Poole, Kaarin M Slotte

16 Apr 2021
21 CFR 1271.180(a)

Procedures to meet core CTGP

Cited by Abby L Mozeke-Baker, Lewis K Antwi

16 Apr 2021
21 CFR 1271.180(a)

Procedures to meet core CTGP

Cited by Abby L Mozeke-Baker, Lewis K Antwi

Investigators

FDA investigators tied to this site in the record.

Garrad R Poole1 insp.
Kaarin M Slotte1 insp.
Abby L Mozeke-Baker1 insp.
Lewis K Antwi1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1271.180(a)Cited across public-safe Form 483 observations3x
21 CFR 1271.200(a)Cited across public-safe Form 483 observations3x
21 CFR 1271.220(c)Cited across public-safe Form 483 observations3x
21 CFR 1271.230(a)Cited across public-safe Form 483 observations3x
21 CFR 1271.230(c)Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)(1)Cited across public-safe Form 483 observations3x
21 CFR 211.166(a)Cited across public-safe Form 483 observations3x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.198(a)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations3x

Full site report

Get the verbatim findings behind SURGENEX LLC's 2 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat