Protica Takes Proactive Response to FDA Warning Letter

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FDA regulations and compliance are of the greatest importance to Protica. Therefore in response, Protica has been in regular contact and is working closely with the FDA to take the necessary actions to close all non-conformances

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Protica is positive that these steps will maintain its full compliance with all FDA laws and regulations, provide the highest quality products to their customers, and reaffirm their continuing commitment to good manufacturing processes

On February 17, 2012, Protica received an FDA warning letter. FDA regulations and compliance are of the greatest importance to Protica. Therefore in response, Protica has been in regular contact and is working closely with the FDA to take the necessary actions to close all non-conformances.

Protica has retained the services of a well respected consulting firm to assist in preparing the response and identifying and implementing any necessary corrective actions. Headquartered in Alexandria, Virginia, EAS Consulting Group, LLC (EAS) specializes in Food and Drug Administration (FDA) regulatory matters. One of their areas of expertise is to assist domestic and foreign food and dietary supplement firms to comply with applicable laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives, and is assisted by an extensive network of consultants with many years of FDA and industry experience.

Protica has committed to becoming SQF (Safe Quality Foods) Certified. An increasing number of Major North American retailers are requiring food safety certification from their suppliers. SQF certification meets these requirements and provides assurance that product, process, and service comply with regulatory using scientifically proven standards for accuracy and safety. In addition to its focus on accuracy and food safety, SQF allows suppliers to demonstrate their excellence in adhering to the highest quality standards of handling, preparation, and processing.

Protica is positive that these steps will maintain its full compliance with all FDA laws and regulations, provide the highest quality products to their customers, and reaffirm their continuing commitment to good manufacturing processes.

About EAS Consulting Group, LLC

EAS Consulting Group, LLC (EAS), headquartered in Alexandria, VA, specializes in Food and Drug Administration (FDA) regulatory and compliance matters. Our prime focus is to assist domestic and foreign pharmaceutical, medical device, tobacco, food, dietary supplement, and cosmetic firms comply with applicable FDA laws and regulations. EAS is staffed with former FDA compliance and inspection officials and industry executives, and is assisted by an extensive network of consultants with many years of FDA and industry experience. Our consultants and auditors are located strategically throughout the U.S. and Europe.

About Protica

Founded in 2001, Protica, Inc. is a research-based nutraceutical firm headquartered in Whitehall, Pennsylvania. In its privately owned 250,000 square foot facility, Protica manufactures capsulized foods, such as Profect® ready-to-drink liquid protein beverage, Isometric® ready-to-drink meal replacement shot, Fruitasia® ready-to-drink fruit and vegetable shot, Protein Gem® ready-to-eat healthy gelatin, Protein Twist® ready-to-eat protein candy, Pediagro® ready-to-drink children's meal replacement, Proasis® all natural ready-to-drink liquid protein shot, and many other brands in ready-to-drink and ready-to-eat form. To learn more about Protica please visit http://www.protica.com

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Alex Roth
Protica, Inc.
610-832-2000 253
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