LogoAuditFlow
FDA Compliance Consultancy

"We went from a warning letter to a perfect score in 90 days. The auditor closed the binder, looked up, and said he'd never seen documentation this clean."

Portrait of Marcus Webb, Quality Assurance Director, wearing business attire

Marcus Webb

VP of Quality Assurance · Midwest Protein Co.

Ready-to-Eat Manufacturing · 3 facilities

SQF Level 3 Certified

340+

Facilities Certified

98%

First-Pass Audit Rate

47

Zero-Observation Results

Risk Assessment

Which of these is keeping you
up at 3 a.m.?

Every one of these is a 483 observation waiting to happen. We've seen each of them — and cleaned them up — more times than we can count.

Supplier COAs Piling Up Unreviewed

Your approved supplier list has 47 vendors. You've verified certificates of analysis for 12 of them. The other 35 are in a shared drive folder last opened in October. FDA's first question on a 483 is always about supplier verification.

Corrective Actions on Sticky Notes

Your last internal audit found 9 non-conformances. Three got fixed, four got sticky-noted, two were emailed to someone who no longer works there. When a third-party auditor asks for your CAPA log, you'll be searching three inboxes and a whiteboard.

Your PCQI Left Six Months Ago

The Preventive Controls Qualified Individual who built your food safety plan is at a competitor now. Nobody has been re-trained. The plan hasn't been reanalyzed. FSMA §117 requires annual reanalysis — and FDA knows exactly how to spot a plan that's been orphaned.

Six Retailer Audit Schemes, Zero Alignment

Whole Foods wants GFSI. Costco wants SQF. Your regional chain runs their own proprietary checklist. You're maintaining six separate sets of documentation for the same physical facility — and when they overlap, nobody's sure which version is current.

Here's how we fix every single one.
Our Services

Every problem named.
Every solution documented.

We don't do general consulting. Each engagement maps directly to a named compliance gap — and we don't close the file until the gap is closed.

Problem: Scattered supplier documentation

Supplier Verification Program

Before

COAs in 4 different folders, 3 email threads, and one person's desktop

After

Centralized approved supplier database, automated COA tracking, and a verification workflow your QA team can maintain in under 2 hours per week.

FSMA §117 / SQF 2.1

Problem: CAPA logs that don't hold up

Corrective Action Management System

Before

Non-conformances tracked in a spreadsheet nobody updates, or not tracked at all

After

Structured CAPA workflow with root cause analysis templates, effectiveness checks, and a paper trail that satisfies any third-party auditor on day one.

SQF 5.4 / BRCGS 3.7

Problem: Orphaned food safety plans

PCQI-Led Food Safety Plan Rebuild

Before

A food safety plan written two years ago by someone who's gone, never reanalyzed, with hazard analyses that don't match current production lines

After

Updated, FSMA-compliant food safety plan with current hazard analysis, validated preventive controls, and an internal PCQI trained to maintain it independently.

FSMA PCQI / FSSC 22000

Problem: Multi-scheme audit chaos

Unified Compliance Architecture

Before

Six retailer audit checklists maintained separately, with no master document control system

After

A single integrated QMS that maps to SQF, BRCGS, FSSC 22000, and retailer-specific requirements simultaneously — one update propagates everywhere.

SQF / BRCGS / FSSC 22000
The Engagement

From gap to certified
in 90 days.

Every engagement follows the same proven arc. The timeline is aggressive because compliance gaps don't wait for your schedule.

1
Days 1–7

Gap Assessment

We walk your floor with ATP swabs and thermal loggers. We read every page of your HACCP binder — even the parts that haven't been updated since the Obama administration. You get a prioritized gap report within 5 business days.

Prioritized Gap Report + Risk Matrix
2
Days 8–30

Documentation Overhaul

We rebuild your food safety plan, supplier verification program, and CAPA system from the ground up — or we audit and revise what you have. Every document is formatted to the exact standard you're targeting.

Updated FSSP + Supplier Database + CAPA Log
3
Days 31–60

Training & Verification

Your team learns to operate the system without us. We run mock internal audits, train your designated PCQI, and verify that monitoring records are being completed correctly at every control point.

Training Records + Mock Audit Report + Sign-off
Days 61–90

Audit Readiness & Day-Of Support

We conduct a final pre-audit review, sit with you during the opening meeting, and are on-call for the entire audit day. When the auditor flips your logbook closed and nods — that's the moment we've been building toward.

Audit Certificate + Ongoing Retainer Option

Every engagement begins with a no-cost gap assessment call.

Get Started

Your gap assessment
starts here.

Three questions. Two minutes. A clear picture of where you stand before your next audit.

Step 1
Step 2
Step 3

Tell us about your facility

Free Pre-Audit Readiness Checklist

47 line items across supplier verification, CAPA, sanitation, and documentation control. The same checklist our auditors use on day one of every engagement.

Certifications We Work With

SQF
BRCGS
FSSC 22000
FDA PCQI

"We had our first Whole Foods PO and needed SQF Level 2 in 60 days. AuditFlow made it happen. The auditor had zero observations."

Portrait of Priya Nair, Founder of Clean Plate Foods, smiling in professional setting

Priya Nair

Founder, Clean Plate Foods · Chicago, IL