White Bear Lake, MN - Jean-Francois Marcopoulos, Chief Operating Officer, Chemi S.p.A., Milan, Italy, proudly announces that manufacturing facilties located in Milan and Patrica, Italy, have been inspected by the Department of Health & Human Services, Public Health Service, of the Food and Drug Administration, and both have been granted acceptable status under FDA’s strict inspection guidelines.
The FDA provided an Establishment Inspection Report (EIR) to Chemi S.p.A. at the conclusion of each inspection, as the FDA is working diligently to make the regulatory process and its activities more transparent to this highly regulated industry. Chemi S.p.A. will continue in its efforts to ensure continued compliance with its current good manufacturing practices (cGMPs).
Scott Hagerman, president of Chemi Nutra said, “We are extremely pleased that our manufacturing facilities have satisfactorily passed another round of FDA inspections. Since our specialty nutraceutical ingredient products, including SerinAid® PhosphatidylSerine (PS), are manufactured in the Patrica pharmaceutical plant, our customers can rest assured that Chemi Nutra and its products are well positioned for the new GMP regulations that are being phased in to the nutritional products industry.”
Chemi Nutra is the US business unit of parent company Chemi S.p.A., a privately held pharmaceutical and nutraceutical company based in Milan, Italy. Chemi, with cGMP certified manufacturing facilities in Italy and Brazil, is best known in the US nutritional arena for its introduction of phosphatidylserine (PS), the popular dietary supplement which has been granted two health claims by the FDA, and is used to enhance learning, memory, and concentration.
Julie Montzka, [email protected], 866.907.0400