Unitec can help you navigate audits to review the efficiency of your operations and improve quality output. Our assessors and training consultants are formally trained with the qualification of either the certified lead assessors internationally. Our team will identify what regulations and criteria apply to your facility, and determine if personnel, setup and operation system are adhering to compliance procedures, requirements and corporate policies.

Other than the specific customized methodology, our assessment would strictly complies with the global assessment criteria and methodologies of of ISO 19011- Guidelines for auditing management systems, ISO 17021 – Conformity assessment & FDA Quality System Regulation Part 820.


Benefits of a Unitec Facility Audit

  • Identify and correct compliance issues
  • Build the facility's and people knowledge of compliance
  • Improve facility safety and to help reduce facility's and personal liability and risk
  • Enhance awareness and understanding of regulations and corporate requirements
  • Demonstrate the facilitys commitment to compliance
  • Improve efficiency and cost-effectiveness of the facility's compliance program

Auditing Standards

  • CGMP, GMP, GMPC consultation and assessment
  • International recognized social corporate compliance
  • Production facility assessment
  • Material control and integrity management
  • FDA Facility Registration
  • Quality assurance and technical audit
  • Production capacity and capability assessment
  • On-site witness 'inspection and tests
  • On-site material and inventory scanning

Contact us with your enquiry and quote?

Our Office


California, USA


Hong Kong



886 2-2365-5800

Dongguan, Guangdong

Unitec is accredited in the U.S.A. by ANAB and CPSC. Our accredited testing services cover the latest regulations and legal requirements of major world markets, including the U.S.A., Canada, Europe and beyond, and their corresponding state and province-wide laws.