FDA/GMP design-build

One contractor. One contract. One audit-ready facility.

W SUN Construction is a Southern California design-build general contractor specializing in FDA/GMP-compliant manufacturing facilities. We take your plant from concept to a commissioned, certified, audit-ready building — on time and on budget.

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Design-BuildOne accountable team
FDA / GMPManufacturing facilities
Class BGeneral Building Contractor
CSLB License#1143431

Capabilities

Design, build, and qualify the whole facility.

One team coordinates the building, cleanroom, mechanical systems, and turnover package.

01

New GMP Facility Construction

Ground-up plants built to FDA cGMP from day one.

02

Cleanroom Design-Build

ISO Class 5–8 controlled environments, engineered and built by one team.

03

Expansions & Retrofits

Grow inside your operating plant without shutting it down.

04

MEP & Cleanroom HVAC

In-house mechanical: the air system your classification depends on.

05

Commissioning & Validation Support

IQ/OQ/PQ documentation and certification, ready for inspectors.

06

Audit Readiness & Remediation

We fix the 483 findings — and build so the next one never happens.

Why W SUN

Accountability from concept through qualification.

A general contractor built around regulated manufacturing, with the disciplines that determine whether the facility performs.

01One contract, one team — design, engineering, and construction under one roof.
02We engineer for the inspection, not just the ribbon-cutting.
03In-house MEP means the air system isn't someone else's problem.
04Built to expand — modular walls and planned utility capacity for your next line.

Built for production. Engineered for inspection. Ready for what comes next.

Food & Beverage

Sanitary, washdown-ready plants built to 21 CFR Part 117.

Dietary Supplements

Facilities that meet 21 CFR Part 111 from slab to ceiling.

Pharmaceutical

ISO-classified cGMP environments, sterile to non-sterile.

Pet Food

Animal-food plants built to 21 CFR Part 507 and state feed standards.

Cosmetics

Hygienic GMP facilities aligned with ISO 22716.

Data Centers

ISO Class 8 controlled environments with ASHRAE-grade contamination control.

How we deliver

Five phases. One accountable team.

The same team carries the operating requirements from first concept through validated turnover.

01

Plan

We map your product, process, and regulations to a facility concept and a real budget.

02

Design

GMP zoning, classifications, and airflow engineered before construction starts.

03

Build

Cleanroom and MEP construction with contamination-controlled sequencing.

04

Commission

IQ/OQ/PQ, certification, and an audit-ready turnover package.

05

Support

Requalification and maintenance that protect your validated state.

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The W SUN approach

The building must work for the process.

We start with product flow, people flow, sanitation, utilities, pressure relationships, and the inspection path. Then we coordinate the facility around those requirements.

Design-build general contracting
Cleanroom and MEP coordination
Commissioning and validation support

Planning a regulated facility?

Tell us what you make, where you are, and what the facility must achieve.

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