OGDEN, Utah—Mineral Resources International Inc. (MRI), a dietary supplement manufacturer of all-natural, premium ionic minerals and supplier of GRAS (generally recognized as safe) mineral ingredients, completed its successful cGMP (current good manufacturing practices) inspection by FDA. FDA found no deficiencies or areas where corrective action notices were issued.
MRI’s manufacturing facility was the subject of a random, weeklong, onsite audit Aug. 31 to Sept. 8, 2011 to ensure the company’s compliance with cGMPs. Pursuant to the Code of Federal Regulations, Title 21, Part 111, 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.
“FDA inspector said 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."
Kris McDonald, Quality Assurance Director and Lab Manager for MRI, added: “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. 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.