$1.6 Billion Global Pharmaceutical Leader Improves FDA Inspection Readiness

Introduction

For nearly 140 years, this global pharmaceutical manufacturer has delivered trusted, affordable health and wellness products to consumers worldwide. The organization is a top ten player in the European Consumer Self-Care market and the largest store brand provider of over-the-counter products and infant formula in the United States.

Its operations span a complex global manufacturing and distribution network. The company develops and manufactures over 400 private label formulations across thousands of SKUs, serving more than 130 U.S. customers. Its expertise in mass customization allows a single national brand product to translate into hundreds of unique store brand SKUs tailored to retailer requirements.

Operating at this scale requires strict adherence to FDA regulations, Current Good Manufacturing Practice (CGMP), and robust quality systems. Inspection readiness is not a periodic exercise. It requires clear procedures, documented training, and consistent oversight of contractor activities every day.

The Challenge

Managing Contractors and Ensuring FDA Inspection Readiness 

FDA-regulated pharmaceutical manufacturers must ensure that contractor personnel are trained on site-specific Standard Operating Procedures (SOPs) before performing work.

In 2025, the FDA announced expanded use of unannounced inspections at foreign manufacturing facilities supplying essential medicines to U.S. consumers. This increased scrutiny reinforces the need for continuous inspection readiness across pharmaceutical operations.

In recent years, inadequate or insufficiently detailed SOPs have consistently appeared in inspection findings under 21 CFR 211.22(d). Between 2015 and 2025, 71% of FDA warning letters included citations related to insufficient or poorly documented written procedures, making it one of the most persistent compliance gaps across the industry. Training documentation gaps under 21 CFR 211.25(b) also remain common observations. These issues often stem from inconsistent processes, unclear procedural ownership, or lack of centralized visibility.

Prior to partnering with Veriforce, the company managed contractors and their employees through manual and inconsistent processes across sites. There was no centralized system to confirm that contract workers had completed required SOP training before arriving onsite; which created several challenges:

• Limited visibility into contractor training status
• Administrative burden for internal quality and operations teams
• Increased likelihood of receiving an FDA warning letter or citation or an FDA training observation
• Difficulty demonstrating documentation integrity and CGMP alignment

For a pharmaceutical manufacturer operating under strict regulatory oversight, this approach created unnecessary compliance risk.

The Veriforce Solution

Building a Structured, Inspection-Ready Contractor Framework

Veriforce worked collaboratively with EHS, quality, operations, procurement, human resources, and security stakeholders in the company  to establish a standardized contractor management framework. The goal was not to shift ownership, but to enhance visibility, consistency, and documentation control.

The solution focused on three core areas:

1. Contractor Company Qualification
   The pharmaceutical manufacturer defines safety and compliance requirements for contractors to complete within CompliancePro, including verification of OSHA recordables, EMR, incident rates, insurance documentation, and more.
2. Contract Worker-Level SOP Training
   Contract workers are assigned required site-specific SOPs before arriving onsite. Completion is verified and tracked, ensuring only properly trained individuals enter regulated manufacturing environments.
3. Documentation Integrity and Visibility
   Training records and contractor qualification data aremaintained within a centralized system that supports data integrity principles aligned with ALCOA standards: attributable, legible, contemporaneous, original, and accurate.

This structured framework strengthened the organization’s ability to demonstrate CGMP compliance and provide defensible documentation during regulatory review.

Implementation

A Phased Rollout Designed to Scale

The program began with onboarding select U.S. facilities into CompliancePro. Each site followed a structured 90-day implementation plan, prioritizing

• Contractor onboarding and qualification
• Alignment of SOP requirements to operational workflows
• Role-based training assignments for contractor personnel
• Cross-functional education sessions for internal stakeholders
• Clear communication to contractors regarding compliance expectations

Veriforce facilitated training sessions, supported documentation alignment, and collaborated closely with internal teams to ensure the system reflected site-specific needs.

This partnership approach reinforced internal accountability while strengthening standardization across facilities.

Results

Measurable Efficiency Gains and Stronger Compliance Oversight

Today, the global pharmaceutical leader uses Veriforce to improve cross-department collaboration and actively manage nearly 2,000 contractors across multiple U.S. manufacturing facilities. 66,803 active training courses are assigned and maintained across the contractor workforce; resulting in an 8-to-10-week productivity gain for internal administrative team members. Beyond time savings, the company ensured:

• Immediate pass down of site-specific SOPs to contractors
• Pre-qualification and verification of contract worker credentials before onsite arrival
• FDA inspection readiness
• Insurance verification and MSA workflow execution

By centralizing contractor oversight and training verification, the organization improved its ability to demonstrate CGMP alignment and respond confidently to inspection requests.

Conclusion

Strengthening FDA & CMPG Compliance in Pharmaceutical Manufacturing

In today’s heightened regulatory climate, contractor oversight is a critical component of FDA compliance, CGMP execution, and quality system integrity. Training documentation and procedural control are often among the first areas reviewed during inspections.

Through collaboration with Veriforce, this global pharmaceutical leader strengthened its contractor compliance framework, improved documentation consistency, and enhanced inspection readiness across multiple facilities.

Strengthen FDA Inspection Readiness

Pharmaceutical manufacturers face increasing regulatory scrutiny. The FDA and other regulatory agencies view contractors as extensions of pharmaceutical manufacturers’ operations. Training documentation, SOPs, and data integrity remain among the most frequently cited issues in FDA warning letters.

Veriforce helps global pharmaceutical and life sciences leaders ensure site specific SOPs are centralized and consistently communicated to contractors and third-party manufacturers.

Connect with our team to learn how we can help your organization reduce compliance risk, improve documentation integrity, and strengthen inspection readiness across your manufacturing network.