The US FDA inspection was conducted during 3 days at its production site in Malaysia.
ExcelVite’s production plant and Quality Management System (QMS) were inspected according to FDA’s Code of Federal Regulation – Title 21 Current Good Manufacturing Practices (21 CFR-cGMP).
There was no non-compliance within ExcelVite’s systems and hence, no Non-Conformance was issued at the end of the inspection.
“As part of the company’s commitment to ensure that our QMS is compliant with current good manufacturing practice (cGMP), we are proud to know that our existing system meets the quality criteria and requirements of the US FDA. It is of utmost importance to ensure that the entire system is adhered to and implemented at all times in order to ensure product quality and safety, which is our commitment to customers,” says Ms Y.T. Chan, Quality Assurance Manager of ExcelVite.
“Being a dedicated and large manufacturer and exporter of palm phytonutrients, especially EVNol natural full spectrum tocotrienol complex and EVTene natural mixed-carotene complex, ExcelVite is committed to the highest level of product quality, safety and manufacturing standards.
In addition to enforcing cGMP PIC/S Guide (Pharmaceutical Inspection Co-Operation Scheme’s Guide to Good Manufacturing Practice for Medicinal Products), ExcelVite is proud to have achieved this important milestone in the FDA audit.
It represents and underscores our compliance with the 21 CFR-cGMP Guidelines that allows for continuous export to the United States,” says W.H. Leong, CEO of ExcelVite.
“I want to congratulate and thank Team EV for their effort in upholding the most stringent production and quality systems in its daily operation that have led to the success in this important FDA inspection."
The commitment and conscientiousness shown are commendable and highly appreciated. The company is proud to have such a team and we look forward to implementing continuous improvement efforts to maintain and sustain our leadership position in the market,” added Mr Leong.
This is the second time that the US FDA has inspected ExcelVite’s manufacturing facility located at Chemor, Perak, Malaysia. The first inspection was conducted in 2012.
