Quality Assurance

ENCO Pharmaceutical Development, Inc. is dedicated to maintaining the full compliance of its operations with all regulatory authorities. Our laboratories operate under cGMP guidelines to ensure that your projects will conform to applicable regulations and guidance’s.

Quality Assurance Responsibilities
The EPDI Quality Assurance group:
  • Hosts all on-site audits,
  • Conducts off-site inspections of third-party organizations,
  • Conducts in-house process audits to verify operational compliance with policies and procedures,
  • Maintains Document Control, Training and other compliance related systems,
  • Reviews data, reports and other technical documents.

Audit History

The company has been audited for compliance with federal and international standards on an ongoing basis by a variety of institutions. Audits are directed by regulatory agencies, accrediting organizations, customers, and third parties.

A summary of our most recent regulatory inspections follows:

Jacksonville, FL Facility
  • FDA Audit - May 2016 - No 483's
  • DEA Inspection. Registered for Schedules II-V.

Cary, NC Facility
  • FDA Audit - January 2018 - No 483's
  • NC Controlled Substances, via NC HHS - Registered for Schedules II-V (NC II-VI).

Accreditations / Registrations

The company maintains numerous state, federal, and international accreditations and registrations across its locations. Current accreditations / registrations can be found on our Accreditations page.

Formulation |  Analytical Methods |  Stability Studies |  Raw Materials |  Characterization |  Medical Devices |  Quality Assurance

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QA Milestones
- FDA registered

- No FDA issued 483's

- DEA license