|By PR Newswire||
|April 16, 2014 10:00 AM EDT||
CHARLOTTE, N.C., April 16, 2014 /PRNewswire/ -- On April 10, 2014 the U.S. Food & Drug Administration (FDA) issued a "Closeout" letter to Prodigy Diabetes Care to formally conclude the regulatory action that resulted in a Warning Letter on February 22, 2013.
Since the original site inspection of Prodigy in March 2012, and in response to the February 2013 letter, Prodigy has worked with the FDA to address and correct the issues identified through that inspection. The FDA Atlanta District Director issued the Closeout letter after the FDA conducted an unannounced inspection of Prodigy in early January, 2014.
Prodigy CEO Rick Admani voiced his appreciation for the effort made by the FDA to identify the issues of concern and to work through the corrective process with Prodigy. "Though I wish we had never received a Warning Letter, Prodigy is a better company today because of this process," Admani said. "The FDA identified some issues concerning our reporting and documentation processes that required attention and improvement. We conducted a full review and revision of our policies and manuals, and we are better for that opportunity."
In the meantime, OK Biotech Co., Ltd., the dedicated manufacturer of Prodigy products, has received good marks after several audits by customers of Prodigy, an independent regulatory and GMP auditor in Australia, a European Community (CE mark) auditor, and the Taiwanese Ministry of Health. OK Biotech has been re-certified for compliance with the governing manufacturing standard, ISO 13485.
Admani highlighted that, "No agency or other auditor has identified any actual product defects or product safety concerns related to Prodigy products. Unlike several major manufacturers, some of whom have had as many as three Class I product recalls during the past year, Prodigy has never had a manufacturing error or defect that has resulted in a product recall."
Prodigy Diabetes Care has developed a number of innovative products for people with diabetes, such as audible meters, while also making them affordable. The major manufacturers sell their test strips for $1.00 or more per strip, Prodigy sells its No Coding Test Strips for about 12 cents per strip. With over 1.7 million meters distributed worldwide, the combination of high quality and low prices allows many people with diabetes to test regularly, rather than pay such high prices for test strips, or worse, go without testing because they can't afford it. Whether a person with diabetes is privately or publicly insured, or purchases supplies with cash, Prodigy Diabetes Care products are the right solution to the high cost of diabetes testing supplies.
About Prodigy Diabetes Care, LLC
Prodigy Diabetes Care, LLC is a privately owned importer and distributor of diabetes testing supplies. Prodigy, located in Charlotte, NC, distributes its products throughout the U.S. and world.
SOURCE Prodigy Diabetes Care, LLC