FDA-Inspected Site

NexCell Scientific Inc

1 FDA inspection is on record for NexCell Scientific Inc in Irvine, United States.

483· Form 483 issued

Irvine, United States · Last updated August 15, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-02-05.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Dec 2025 – 5 Feb 2026Biologics483View 483 →

Observations on record

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

5 Feb 2026
21 CFR 1271.47(a)

Design of procedures to ensure compliance

Cited by Creighton T Tuzon, Eric Zhu

5 Feb 2026
21 CFR 1271.50(a)

Responsible person to determine, document

Cited by Creighton T Tuzon, Eric Zhu

5 Feb 2026
21 CFR 1271.55(a)(3)

Summary--records used to make determination

Cited by Creighton T Tuzon, Eric Zhu

5 Feb 2026
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Creighton T Tuzon, Eric Zhu

5 Feb 2026
21 CFR 1271.85(b)(2)

SOP for release; reactive for CMV

Cited by Creighton T Tuzon, Eric Zhu

Investigators

FDA investigators tied to this site in the record.

Eric Zhu1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.50(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1271.85(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.150(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(c)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.28(b)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind NexCell Scientific Inc's 1 Form 483

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