FDA-Inspected Site

Alliance Medical Products, Inc.

19 FDA inspections are on record for Alliance Medical Products, Inc. in Irvine, United States.

483· Form 483 issued

Irvine, United States · Last updated July 9, 2026

Overview

  • 19 FDA inspections are on record.
  • 11 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-11-07.

At a glance

Inspections

19

Form 483s

11

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 Oct 2025 – 7 Nov 2025Human Drugs483View 483 →
1 May 2023 – 5 May 2023Human DrugsClean
10 May 2021 – 21 May 2021Human Drugs483View 483 →
4 Feb 2019 – 14 Feb 2019Human Drugs483On file
24 Apr 2017 – 26 May 2017Human Drugs483View 483 →
17 Aug 2015 – 21 Aug 2015Human Drugs483View 483 →
14 Jul 2014 – 25 Jul 2014Human DrugsClean
10 Jul 2013 – 16 Aug 2013Medical Devices & Rad Health483View 483 →
16 Apr 2012Not recorded483View 483 →
23 Mar 2011Not recorded483View 483 →
3 Feb 2011Not recordedClean
3 Sep 2010Not recorded483View 483 →

Observations on record

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

7 Nov 2025
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Christopher R Czajka, Anney Lin

7 Nov 2025
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Christopher R Czajka, Anney Lin

7 Nov 2025
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Christopher R Czajka, Anney Lin

7 Nov 2025
21 CFR 211.42(c)(10)(v)

Cleaning System

Cited by Christopher R Czajka, Anney Lin

21 May 2021
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Bryan A Galvez, Joel D Hustedt

Investigators

FDA investigators tied to this site in the record.

Anney Lin1 insp.
Dogbeda F Mackenzie1 insp.
Linda Thai1 insp.
Linda L Ng1 insp.
Vashti E Bocker1 insp.
Vickie L Anderson1 insp.
Cntrctmntr Anderson1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations8x
21 CFR 211.192Cited across public-safe Form 483 observations8x
21 CFR 211.113(b)Cited across public-safe Form 483 observations7x
21 CFR 211.22(d)Cited across public-safe Form 483 observations6x
21 CFR 211.68(a)Cited across public-safe Form 483 observations6x
21 CFR 211.160(a)Cited across public-safe Form 483 observations5x
21 CFR 211.110(a)Cited across public-safe Form 483 observations4x
21 CFR 211.165(e)Cited across public-safe Form 483 observations4x
21 CFR 211.165(f)Cited across public-safe Form 483 observations4x
21 CFR 211.68(b)Cited across public-safe Form 483 observations4x
21 CFR 211.25(a)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(iii)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(3)Cited across public-safe Form 483 observations3x
21 CFR 211.63Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.22(c)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.167(a)Cited across public-safe Form 483 observations1x
21 CFR 211.167(c)Cited across public-safe Form 483 observations1x
21 CFR 211.180(b)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(10)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(5)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Alliance Medical Products, Inc.'s 11 Form 483s

Source PDFs, verbatim observations, 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