Expert Oversight During Probation, Consent Decrees, & Regulatory Enforcement
Pharmacies, hospitals, and 503Bs facing disciplinary action may be placed on probation by state Boards of Pharmacy. GMP facilities may become subject to FDA consent decrees or warning letters requiring formal remediation and ongoing oversight.
In these high-risk situations, regulators often mandate an independent, board- or FDA-approved consultant to monitor compliance, oversee corrective actions, and report progress throughout the term of enforcement.
What’s Included
Fulfill Agency-ordered monitoring requirements
Conduct recurring audits to assess compliance with probation or consent terms
Provide written reports at required intervals
Support site remediation plans, CAPA tracking, and operational turnaround
Help you stay operational and regain trust with regulators
Whether you're under board scrutiny or FDA oversight, we provide experienced, defensible support to help you move forward.
Our Holistic Approach
Gap Analysis Audit
CAPA Planning
Remediation Implementation
Education
Compliance Report