FDA & DEA Compliance
Our facilities maintain full regulatory compliance with FDA registration, DEA licensing, and adherence to federal and state regulations.
FDA Compliance
Food and Drug Administration
Medivant Healthcare facilities are registered with the FDA as pharmaceutical manufacturing establishments. We maintain compliance with all applicable FDA regulations including 21 CFR Parts 210 and 211 for current Good Manufacturing Practice (cGMP).
Key Compliance Areas
- Facility registration and drug establishment listing
- cGMP compliance for drug products
- Quality management system oversight
- Adverse event reporting procedures
- Regular inspection readiness
DEA Compliance
Drug Enforcement Administration
As a manufacturer of controlled substances, Medivant Healthcare maintains DEA registration and adheres to all requirements under the Controlled Substances Act. Our facilities implement comprehensive security and accountability measures.
Controlled Substance Protocols
- DEA Schedule II-V manufacturing authorization
- Secure storage and handling procedures
- Complete chain of custody documentation
- Inventory reconciliation and reporting
- Employee background verification
Quality Management Systems
Document Control
Comprehensive SOPs, batch records, and validation documentation maintained under strict version control protocols.
Internal Audits
Regular internal audits assess compliance with cGMP requirements and identify opportunities for continuous improvement.
CAPA Process
Robust Corrective and Preventive Action system ensures systematic resolution of quality issues and prevention of recurrence.
Our Regulatory Commitment
Regulatory compliance is not just a requirement—it's fundamental to our mission of providing safe, effective medications to patients. We maintain ongoing relationships with regulatory agencies and proactively address emerging requirements to ensure uninterrupted supply of critical medications.