The tables below show the changes in the Top 10 483 observations from the 2015 FDA Fiscal Year to the 2016 FDA Fiscal Year, defined as October 1 of the previous year through September 30 of the calendar year. Fewer 483s were found overall, and most … Read More
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By Regina Fullin, Director of Compliance Consulting Services, Compliance Team, Inc. People talk all the time about New Year’s Resolutions, but it seems like people make the same resolutions over and over. The reason for this is that priorities get … Read More
If you ask a pharmaceutical professional about the FDA’s requirements for medical devices, the answer you might get is a vague nod to the understanding that medical device regulations are “less restrictive” than pharmaceutical regulations. What are … Read More
By: Regina Fullin Sr. Compliance/Validation Consultant Compliance Team Inc. Gaining understanding of your organization’s compliance risk can be challenging. It seems like regulators choose a different area of focus each time when … Read More
The NIPP will revolutionize the way the FDA manages pharmaceutical inspections. This article will describe the framework of this initiative, and what it is intended to achieve. In 2015, the FDA announced its five Strategic Priorities for 2015 … Read More
by Regina Fullin, Compliance Consultant at Compliance Team, Inc. Counterfeit medication is a worldwide problem. Many of us in the United States may be surprised to realize that, in some countries, up to 70% of pharmaceutical products are … Read More