06.13.17
ExcelVite has completed its quality audit/inspection by the U.S. Food and Drug Administration (US FDA). The inspection was conducted over three days at the company’s 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 U.S. 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,” said YT Chan, quality assurance manager of ExcelVite.
“Being a dedicated and largest 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,” said WH Leong, CEO of ExcelVite.
This is the second time that the U.S. FDA has inspected ExcelVite’s manufacturing facility located at Chemor, Perak, Malaysia. The first inspection had been conducted in 2012.
“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 U.S. 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,” said YT Chan, quality assurance manager of ExcelVite.
“Being a dedicated and largest 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,” said WH Leong, CEO of ExcelVite.
This is the second time that the U.S. FDA has inspected ExcelVite’s manufacturing facility located at Chemor, Perak, Malaysia. The first inspection had been conducted in 2012.
