Global MedTech Leader Resolves FDA GMP Risk at Acquired Plant
1100+
Cross-functional resources governed across remediation program
100%
Complete GMP compliance restored across the facility
$11.7M
Cost savings achieved through effective delivery oversight
Results
The client achieved full FDA GMP compliance, enabling the resumption of premarket approvals and restoring confidence with regulators. The remediation program was delivered ahead of schedule and below budget, generating $11.7 million in cost savings. In addition, the client now operates with a sustainable compliance model designed to support future inspections, audits, and acquisitions.
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