Month: February 2018

Our mobile compounding center featured in the February issue of Pharmacy Purchasing & Products Magazine

Our mobile compounding center was featured in the latest issue of the PP&P Magazine who showcased our plug and play mobile cleanroom as this months’ new and noteworthy addition to the industry. Our mobile cleanroom modules are built to meet your specific ISO classification, pressure and venting requirements. They are delivered factory tested and fully …

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FDA’s Gottlieb outlines new goals in budget plan, looking to spur drug reviews

President Donald Trump’s budget sought a boost in funding for the FDA and now FDA Commissioner Scott Gottlieb is offering his own take on the initiatives and investments the agency plans to pursue. Plans outlined by Gottlieb include the creation of two new centers related to drug compounding and digital health. Promote Domestic Drug and …

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Kareway Products, Inc. Issues Voluntary Nationwide Recall of Gericare Eye Wash due to Complaints Received on Potential Product Contamination which Compromises Sterility

For Immediate Release January 29, 2018 Contact Consumers Recall Department  recall@kareway.com  310-532-0009   Announcement Kareway Products, Inc is voluntarily recalling 60,000 units of Gericare Eye Wash, Sterile Eye Irrigation Solution, 4 fluid ounces to the hospital, retail or consumer level. The product has been found to have potential microbial contamination which compromises sterility. Risk Statement: The …

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An Analysis Of FDA FY2017 Drug GMP Warning Letters

By Barbara Unger, Unger Consulting Inc. This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree …

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FDA Provides Some Guidance for 503B Facilities

  On January 16th, 2018, FDA Commissioner, Scott Gottlieb, M.D. issued the 2018 Compounding Policy Priorities Plan. This document outlines, what the commissioner describes as, key priorities the agency will pursue to implement the federal law on compounding and to advance the FDA’s public health mission. This plan signals some major changes in compounding regulations …

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