Welcome!

News Feed Item

Prodigy Diabetes Care Moves Forward After FDA Concludes Regulatory Action

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

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"We've discovered that after shows 80% if leads that people get, 80% of the conversations end up on the show floor, meaning people forget about it, people forget who they talk to, people forget that there are actual business opportunities to be had here so we try to help out and keep the conversations going," explained Jeff Mesnik, Founder and President of ContentMX, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
“Being the one true cloud-agnostic and storage-agnostic software solution, more and more customers are coming to Commvault and saying ' What do you recommend? What's your best practice for implementing cloud?” explained Randy De Meno, Chief Technologist at Commvault, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
“delaPlex Software provides software outsourcing services. We have a hybrid model where we have onshore developers and project managers that we can place anywhere in the U.S. or in Europe,” explained Manish Sachdeva, CEO at delaPlex Software, in this SYS-CON.tv interview at @ThingsExpo, held June 7-9, 2016, at the Javits Center in New York City, NY.
"When you think about the data center today, there's constant evolution, The evolution of the data center and the needs of the consumer of technology change, and they change constantly," stated Matt Kalmenson, VP of Sales, Service and Cloud Providers at Veeam Software, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
"We're bringing out a new application monitoring system to the DevOps space. It manages large enterprise applications that are distributed throughout a node in many enterprises and we manage them as one collective," explained Kevin Barnes, President of eCube Systems, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
From wearable activity trackers to fantasy e-sports, data and technology are transforming the way athletes train for the game and fans engage with their teams. In his session at @ThingsExpo, will present key data findings from leading sports organizations San Francisco 49ers, Orlando Magic NBA team. By utilizing data analytics these sports orgs have recognized new revenue streams, doubled its fan base and streamlined costs at its stadiums. John Paul is the CEO and Founder of VenueNext. Prior ...
IoT is rapidly changing the way enterprises are using data to improve business decision-making. In order to derive business value, organizations must unlock insights from the data gathered and then act on these. In their session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, and Peter Shashkin, Head of Development Department at EastBanc Technologies, discussed how one organization leveraged IoT, cloud technology and data analysis to improve customer experiences and effi...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform and how we integrate our thinking to solve complicated problems. In his session at 19th Cloud Expo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm ...
Let’s face it, embracing new storage technologies, capabilities and upgrading to new hardware often adds complexity and increases costs. In his session at 18th Cloud Expo, Seth Oxenhorn, Vice President of Business Development & Alliances at FalconStor, discussed how a truly heterogeneous software-defined storage approach can add value to legacy platforms and heterogeneous environments. The result reduces complexity, significantly lowers cost, and provides IT organizations with improved efficienc...
Organizations planning enterprise data center consolidation and modernization projects are faced with a challenging, costly reality. Requirements to deploy modern, cloud-native applications simultaneously with traditional client/server applications are almost impossible to achieve with hardware-centric enterprise infrastructure. Compute and network infrastructure are fast moving down a software-defined path, but storage has been a laggard. Until now.
"We view the cloud not really as a specific technology but as a way of doing business and that way of doing business is transforming the way software, infrastructure and services are being delivered to business," explained Matthew Rosen, CEO and Director at Fusion, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 19th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world and ThingsExpo Silicon Valley Call for Papers is now open.
Big Data engines are powering a lot of service businesses right now. Data is collected from users from wearable technologies, web behaviors, purchase behavior as well as several arbitrary data points we’d never think of. The demand for faster and bigger engines to crunch and serve up the data to services is growing exponentially. You see a LOT of correlation between “Cloud” and “Big Data” but on Big Data and “Hybrid,” where hybrid hosting is the sanest approach to the Big Data Infrastructure pro...
In his session at 18th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., and Logan Best, Infrastructure & Network Engineer at Webair, focused on real world deployments of DDoS mitigation strategies in every layer of the network. He gave an overview of methods to prevent these attacks and best practices on how to provide protection in complex cloud platforms. He also outlined what we have found in our experience managing and running thousands of Linux and Unix ...