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news.H&P Industries, a manufacturer of OTC products, and Triad have finalized the terms of a Consent Decree of Permanent Injunction (Consent Decree) with the US Food and Drug Administration (FDA) for H&P's manufacturing facility in Hartland, WI.
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The Consent Decree is subject to approval by the US District Court in the Eastern District of Wisconsin.
H&P has enlisted an independent expert who will inspect the facility and issue recommendations for further enhancements.
The company will develop a work plan to address these recommendations.
Upon FDA approval of the plan, H&P will be able to resume manufacturing.
The company and the FDA also have agreed the independent expert will review all manufacturing records related to current production to ensure that products released from the facility continue to meet quality standards.
The terms of the Consent Decree also allow H&P to submit a reconditioning plan for the products seized on 4 April 2011.
H&P submitted a Comprehensive Action Plan (CAP) to the FDA to improve quality systems at its manufacturing facility in January 2011.
The Consent Decree allows H&P to continue the work initiated under the CAP and identifies procedures that will help provide additional assurance of product quality to the FDA.
H&P manufactures pharmaceutical products and medical devices for distribution by Triad and other companies.