From failing batches to three production lines in 5 months

A contract manufacturing organization in Florida, licensed for cosmetics, OTC pharmaceuticals and FDA-inspected medical devices.

A licensed contract manufacturer in cosmetics, OTC pharmaceuticals and FDA-inspected medical devices, with real customers and batches that kept failing acceptance tests. Costing and inventory ran on spreadsheets, the balance sheet carried negative inventory, and an ERP had been bought and never made it to test production.

The plant produced emulsions, sprays and gels on a single line, four days a week. Alongside all of that, the 510(k) and OTC regulatory files needed review, and the paper-based quality management system had to be restarted.

1

3

Production lines, running 5 days a week instead of 1 line running 4 days a week

+64%

Revenue in 5 months, from a $198K monthly average in 2024 to $325K in May 2025

57%

32%

Labor cost as a share of revenue, a 44% decrease in 5 months

Operations Diagnosis

What the diagnosis uncovered

We examined the plant’s people, processes, data and infrastructure to find where the operational friction actually sat.

Finding 01

Costing and inventory ran on spreadsheets

Operations relied on an intricate but flawed network of Google Sheets for costing and inventory tracking.

Finding 02

The balance sheet did not hold

It suffered from fundamental accounting flaws: negative inventory, purchases expensed without prior counts, and no work-in-progress tracking at all.

Finding 03

An ERP paid for but never switched on

Purchased and paid for through subscriptions, then given hundreds of hours of implementation, without ever being put into test production.

Finding 04

Severe quality gaps in a regulated plant

Fragile water systems, unvalidated lab testing equipment, and batches failing acceptance tests due to bacterial contamination.

Feeling this kind of friction in your own business?

The Operations Diagnosis looks at your people, process, data and infrastructure. In two weeks you get a written report and a prioritized plan with actionable steps: what to fix first, what it is costing you, and what fixing it is worth.

5.0

Trusted by 40+ SME businesses

Root Cause

Why the batches kept failing

Batches were failing acceptance tests due to bacterial contamination. In a regulated plant the first suspect is facility hygiene, and this plant had severe quality gaps, including fragile water systems.

But the contamination was traced to the product formulation specifications, rather than to facility hygiene alone. That made it a specification problem, not only a cleaning problem.

The Execution

How the plant was turned around

Restructured site management

Top-heavy site management was removed and replaced with flexible, modular teams led by subject matter experts.

Expanded throughput

Plant throughput went from 1 line operating 4 days a week to 3 concurrent lines operating 5 days a week.

Remote-first execution

The turnaround was run remotely, combined with four one-week on-site visits and video and data surveillance checks.

The Result

Where the business stood by May 2025

Monthly revenue reached $325K in May, against a 2024 monthly average of $198K, and labor fell from 57% of revenue to 32%.


The largest customer placed its entire 2025 order upfront. The 510(k) and OTC regulatory files were reviewed and processed, the paper-based quality management system was restarted, and the business was handed over cleanly to a newly appointed COO.

Not sure where your business is losing time or money?

Most founders can feel it before they can name it. Get in touch, tell us what you're seeing, and we'll share what typically sits underneath it.

5.0

5.0

Trusted by 40+ SME businesses