Alliance Medical Products (Siegfried Irvine)

United States

Profile last updated: 2026-10-28

Sterile Fill-Finish

Program data pending ClinicalTrials.gov matching

Profiled

Not yet scored

✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ○ Press ○ EMA GMP ✓ MHRA GMP (1) ✓ HC GMP (7)

Quick Facts: Alliance Medical Products (Siegfried Irvine)

Signal Score: Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters: United States
Website: https://www.siegfried.ch/
Modalities: Sterile Fill-Finish
Active Programs: No ClinicalTrials.gov matches confirmed
Data Sources: FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About Alliance Medical Products (Siegfried Irvine)

Alliance Medical Products (Siegfried Irvine) is a contract development and manufacturing organization (CDMO). Capabilities: Sterile Fill-Finish. 1 manufacturing site registered with the U.S. FDA, the UK MHRA and Health Canada. Website: https://www.siegfried.ch/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

Alliance Medical Products (Siegfried Irvine) FDA Inspection History

2025-11

NAI VAI OAI

Date	Site	Type	Observations	Classification
2025-11-07	Alliance Medical Products, Inc. Irvine, California Company-level	Drug Quality Assurance	Yes	Voluntary Action Indicated (VAI)

Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Alliance Medical Products (Siegfried Irvine) FDA 483 Findings 4 observations · 2025-11-07 → 2025-11-07 ?

By subsystem

Environmental Monitoring 2 (50.0%)
Laboratory Controls 1 (25.0%)
CAPA 1 (25.0%)

By severity

4 — Serious: 2
3 — Moderate: 2
Repeat observations: 0

Most severe findings

Serious (4) Environmental Monitoring 2025-11-07 21 CFR 211.113(b)

Validation lacking for sterile drug products

"Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process."
Serious (4) Environmental Monitoring 2025-11-07 21 CFR 211.42(c)(10)(v)

Cleaning System

"Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions."
Moderate (3) CAPA 2025-11-07 21 CFR 211.192

Extent of discrepancy, failure investigations

"Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy."

About this data →

Alliance Medical Products (Siegfried Irvine) MHRA GMP Compliance 1 certificates

2014-10

Compliant Non-Compliant

Certificate	Site	City / Postcode	Inspection Date	Status
UK GMP 36929 Insp GMP 36929/1830558-0003[H]	ALLIANCE MEDICAL PRODUCTS INCORPORATED	92618	2014-10-06	COMPLIANT

Source: MHRA GMDP Database · Retrieved Oct 31, 2026

Hiring Activity 8 open roles Beta

From public job postings on the parent company's careers board, as of Oct 30, 2026. Job postings are signals, not statements by the company; each one below links to the original. How we collect this

open roles

in manufacturing, quality, PD/MSAT, engineering or regulatory (88%)

Trend from Nov 29, 2026

Tracking started Oct 30, 2026. 30-day change shows after 30 days, 90-day after Jan 28, 2027.

By function

Manufacturing & operations 2

Quality (QA / QC) 3

Engineering & facilities 2

Commercial, BD & client projects 1

By site

Irvine CA
2 mfg/ops · 3 QA/QC · 2 eng. · 1 other 8

Latest postings

Sr Production Planning Specialist_R26 Manufacturing & operations · Irvine CA

Site Engineering, Maintenance Head_R26 Engineering & facilities · Irvine CA

Quality Assurance Associate I, 2nd Shift_R26 Quality (QA / QC) · Irvine CA

Project Manager II, Pharmaceutical Manufacturing_R26 Commercial, BD & client projects · Irvine CA

Project Engineer III_R26 Engineering & facilities · Irvine CA

Microbiology Lab Technician II, 3rd Shift _R26 Quality (QA / QC) · Irvine CA

Manufacturing Engineer II, Process Expert _R26 Manufacturing & operations · Irvine CA

Manager Quality CQV_R26 Quality (QA / QC) · Irvine CA

Coverage: read from the parent company's careers board and kept only postings at this business's sites (group board filtered to the profile site (Irvine)). Roles outside those sites are left out, and some of this unit's roles may be missed. Function groups come mainly from job titles (about 84% match a hand check), and modality words from titles only, so both are approximate.

Source: siegfried.wd103.myworkdayjobs.com · Checked Oct 30, 2026 · Tracking since Oct 30, 2026

Frequently Asked Questions About Alliance Medical Products (Siegfried Irvine)

How many FDA inspections does Alliance Medical Products (Siegfried Irvine) have on record?

CDMO Signal tracks 1 FDA inspection for Alliance Medical Products (Siegfried Irvine), sourced from the FDA inspection database. See the full inspection history above.

Has Alliance Medical Products (Siegfried Irvine) received an FDA warning letter?

CDMO Signal has no FDA warning letters on record for Alliance Medical Products (Siegfried Irvine).

Does Alliance Medical Products (Siegfried Irvine) hold EMA or MHRA GMP certificates?

CDMO Signal tracks 1 MHRA GMP certificate for Alliance Medical Products (Siegfried Irvine).

Does Alliance Medical Products (Siegfried Irvine) have a CDMO Signal Score?

Not yet. Alliance Medical Products (Siegfried Irvine) is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.

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