Mineral Resources International, Inc. (“MRI”), a dietary supplement manufacturer of authentic, all-natural, premium ionic minerals from Utah’s Great Salt Lake and supplier of GRAS (Generally Recognized as Safe) mineral ingredients, announced that it has completed its successful cGMP (current Good Manufacturing Practices) inspection by the U.S. Food and Drug Administration (FDA). The FDA found no deficiencies or areas where corrective action notices, such as FDA Form 483 observations, were issued.
MRI’s manufacturing facility, based in Ogden, Utah was the subject of a random, weeklong, on-site audit August 31 to September 8, 2011 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.”
MRI would also like to thank NSF International and the law offices of Jonathan Emord, Esq. for their valuable assistance in MRI’s preparations for this flawless audit.
The Anderson family, the founders and executive management of MRI, are the pioneers of solar-evaporated, low-sodium, ionic minerals and trace minerals from Utah’s Great Salt Lake. MRI is the only source of concentrated, low-sodium, Great-Salt-Lake- based mineral concentrates that come entirely from 100 percent food-grade dedicated facilities. All of the dietary supplements produced by MRI are manufactured in its facility. In addition to its recent FDA inspection, MRI is cGMP certified through NSF International, Inc., which audits MRI twice annually.
For more information about MRI, visit www.mineralresourcesint.com.
About Mineral Resources International, Inc.:
Founded as the only legal successor-in-interest to the group of companies originally formed in 1969 by the Anderson family, Mineral Resources International, Inc. (MRI) (www.mineralresourcesint.com) specializes in developing, manufacturing, and distributing noteworthy nutritional supplements in liquid, tablet and powder delivery forms, integrating naturally occurring minerals and trace elements harvested from Utah’s Great Salt Lake. Through its close relationship with NorthShore Limited Partnership, its exclusive supplier and government-inspected, food-grade, solar evaporation mineral harvester on the Great Salt Lake, MRI goes to great lengths to ensure an all-natural, GRAS (Generally Recognized as Safe) mineral and trace element product while maintaining consistent standardization, concentration, and balance in each lot. MRI manufactures a complete line of innovative dietary supplements ranging from multi-vitamins to targeted nutritional formulas using all-natural ionic minerals. In addition, MRI provides a complete portfolio of premium, all-natural ionic mineral ingredients for use in supplements, functional beverages and foods. MRI’s products are sold worldwide through a variety of distribution channels including natural products, specialty retail stores, and natural health care practitioners.