OGDEN -- Mineral Resources International, Inc., a dietary supplement manufacturer of ionic minerals from Utah's Great Salt Lake, announced that it has completed its successful first cGMP (current Good Manufacturing Practices) inspection by the U.S. Food and Drug Administration. The FDA found no deficiencies or areas where corrective action notices.
MRI's manufacturing facility, based in Ogden, was the subject of a random, weeklong, on-site audit Aug. 31 to Sept. 8, to ensure the company's compliance with cGMPs. cGMPs are the guidelines that govern the processes, procedures, and documentation that assure that a dietary supplement possesses the identity, strength, composition, quality and purity represented by the manufacturer.
Pursuant to the Code of Federal Regulations, Title 21, Part 111 [http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=111], the FDA conducted a physical inspection of MRI's manufacturing facility and a thorough audit of the company's record keeping including master manufacturing records, batch records, work orders, raw ingredient receiving and holding, product labeling, packaging, employee training and more.
"The FDA inspector said that this was the first inspection where he did not issue a single write up. Obviously, we are very pleased with results of the inspection," stated Bruce H. Anderson, President/CEO of MRI. "We strive to manufacture the finest mineral supplements and ingredients, which make a difference in human health. We feel that the outcome of this inspection speaks volumes about our company's dedication, care, and adherence to quality standards. I am very proud of our employees who work daily to maintain high standards and continue to improve upon the efficiency, quality, and service of our company."
"The positive outcome of this inspection is a milestone for our company. Not only does it validate the quality standards of our products, but it corroborates the hard work and commitment of our team in meeting current GMPs," said Kris McDonald, Quality Assurance Director and Lab Manager for MRI. "We take great pride in our company and products and will continue to comply with cGMPs."