Inspection Readiness & Response
Prepare for FDA Inspections and Respond to Regulatory Findings
When an inspection is imminent or findings require rapid remediation, GMPKit deploys our proven approach, compliance experts, and operational frameworks to achieve inspection readiness in 30-60 days.
The Inspection Readiness Problem
Regulatory inspections expose gaps in quality systems, operational controls, and governance routines— threatening your manufacturing license and client confidence.
Inspection is Imminent
An FDA or regulatory inspection is scheduled, but your site isn't ready—gaps in documentation, unresolved deviations, or unclear accountability threaten a successful outcome.
Findings Require Rapid Response
You've received inspection findings (483s, warning letters) that require immediate remediation—but your team lacks the capacity or expertise to respond effectively.
Operational Systems Aren't Inspection-Ready
Your quality and operations systems don't demonstrate control—batch records are incomplete, deviations are aging, and governance routines are inconsistent.
How GMPKit Solves This
We solve inspection readiness problems by applying our proven approach and GMPKit toolset to your specific situation—combining diagnostics, remediation strategy, governance, and digital visibility.
Diagnose Inspection Readiness Gaps
We use our diagnostic frameworks to assess your site's inspection readiness—identifying gaps in documentation, quality systems, operational controls, and governance routines.
Explore Diagnostic FrameworksDeploy Remediation Strategy
We translate inspection readiness or response requirements into deployable execution plans—prioritizing gaps, assigning resources, and establishing clear timelines.
Learn About Strategy DeploymentImplement Inspection-Ready Governance
We design PDCA-structured routines that demonstrate control to regulators—daily management systems, escalation paths, and performance visibility that prove operational discipline.
Learn About Governance SystemsDeploy Digital Visibility
We implement BatchTrak™ to provide real-time visibility into batch status, deviation aging, and CAPA progress—demonstrating control and accountability to inspectors.
Explore BatchTrak™ DeploymentExpert Intervention When Needed
Our experience, tools, and SME network help us solve inspection readiness problems quickly—deploying regulatory and compliance experts to prepare your team and address findings.
Quality System Architects
We deploy QA experts to redesign workflows, strengthen controls, demonstrate compliance, and prepare your team for regulatory scrutiny.
Manufacturing Experts
When operational systems need strengthening, we bring in manufacturing leaders to implement inspection-ready governance and daily management routines.
Leadership Development Experts
We coach your leadership team on regulatory expectations, inspection readiness, and how to demonstrate operational control to inspectors.
Results You Can Expect
By day 60, you'll be inspection-ready with operational systems that demonstrate control, or you'll have successfully responded to findings with remediation plans that satisfy regulators.
- Inspection-ready in 30-60 days
- Successful inspection outcomes with minimal findings
- Rapid response to 483s or warning letters
- Operational systems that demonstrate control
- Sustained compliance after inspection
Getting Your Strategy Back on Track:
Our experience, tools, and SME network help us solve inspection readiness problems quickly—getting your compliance strategy back on track and protecting your manufacturing license from regulatory action.
Ready to Prepare for Your Inspection?
When an FDA inspection is imminent or findings require rapid remediation, let's discuss how GMPKit can deploy our proven approach to achieve inspection readiness in 30-60 days.