Helping a Biopharma Manufacturer Achieve Successful FDA Inspection

Key Takeaways

• 11 QA consultants and audit trail specialists placed to support an FDA inspection for a biopharmaceutical manufacturer.
• 3 week turnaround time from initial discovery call to placements, including relocation to Iceland.
• Initial 5-month project extended into a further 6 months of follow-up support, including 10 additional QA specialists.
• Successful FDA inspection outcome achieved, with several consultants promoted during the project. 

The Challenge

A biopharmaceutical manufacturer approached EPM Scientific needing urgent inspection-readiness support following FDA regulatory findings.

The business had received an FDA Warning Letter and Form FDA 483 inspectional observations, creating pressure to address quality issues before further regulatory action affected U.S. supply.

The manufacturer needed specialist quality consultants who could relocate to Iceland and support remediation activity at speed. The project required:

• 8 QA consultants to work within QC labs
• 3 audit trail specialists across QA, QC and microbiology
• EU-based consultants willing to relocate for the 5-month program
• Rapid deployment within 3 weeks

The solution

Assembling a specialist project team, EPM Scientific quickly placed the required QA consultants and audit trail experts within the 3-week timeframe by utilizing our extensive network of contract quality specialists. This gave the client immediate support in the areas under regulatory scrutiny, while helping internal teams manage the volume and complexity of remediation work.

As the initial phase progressed, the manufacturer required additional experts for follow-up activity, and EPM Scientific delivered 4 GDP QA specialists and 6 GMP QA specialists focused on batch record reviews.

The project continued for a further 6 months, giving the client access to quality expertise across inspection-readiness, remediation, audit trail review, GDP, GMP and batch documentation.

The result

EPM Scientific’s placements led to a successful inspection for the manufacturer, and the quality of the consultants was key to the project’s outcome. Several contracts were extended, and multiple consultants progressed within the manufacturer’s team. One consultant was promoted three times during the project, showing the value they delivered beyond the original assignment.

Summary

Through rapid action and targeted quality expertise, EPM Scientific helped the manufacturer respond to regulatory pressure, keep remediation activity moving, and achieve a successful inspection. Get in touch with the team today to discuss how we can support your next quality, compliance or remediation project.