Readying for a US FDA Inspection
If your company produces drugs, medical devices or nutraceuticals that fall under US cGMP regulations, your facility is eventually going to be inspected by the U.S. Food and Drug Administration (FDA). The Federal Food, Drug and Cosmetic Act states that domestic drug establishments can be inspected at least one time every two years. The inspections […]
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How To Create and Staff Your FDA Inspection War Room
Latest FDA and cGMP Compliance News To have a successful FDA inspection, your company really should create a war room in advance of the FDA visit. This is a strategic office that should be entirely devoted to giving all of the needed evidence that is requested by an FDA inspector during an audit. Having […]
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Court Tells FDA That FSMA Deadlines Are Required
Latest FDA and cGMP Compliance News The Food Safety Modernization Act, or FSMA, has made major changes in how FDA and the government is monitoring food safety. FSMA has science based standards and controls on food companies, and it directs companies to do hazard analysis and to create strong, preventive control plans. FDA also has […]
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How To Improve Your CAPA System
Latest FDA and cGMP Compliance News FDA reports that more than 50% of the top FDA 483 citations and warning letter observations are always related to CAPA, or corrective and preventive actions. A strong CAPA system is set up to ID and correct faulty processes that cause a nonconformance, and will prevent such a nonconformance […]
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Watch Out for What You ‘Like’ – FDA Is Watching Your Facebook Page
We have noted two recent FDA warning letters that should be a good reminder to drug and supplement companies that FDA is watching their doings on Facebook and Twitter. They are watching them just as much as your corporate websites, in our opinion. AMARC Enterprises, a supplement firm, was warned last month about a […]
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New Warning Letter Analysis – FDA Is Watching Facebook
Latest FDA and cGMP Compliance News FDA has issued some very interesting warning letters in recent days. The first we want to highlight is a warning letter to Pristine Bay LLC. This letter shows FDA’s stance on the requirements of private label distributing companies to make sure that all aspects of production are in full […]
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How to Keep Up With Medical Device Product Demand and Keep Quality High
Latest FDA and cGMP Compliance News There is more demand than ever for medical devices as our population continues to age. Manufacturers of devices find that they have to boost production and also keep fully compliant with FDA quality regulations. It is very important to keep up with demand without sacrificing quality or FDA regulatory […]
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5 Screw Ups That Will Delay Your FDA 510(K) Approval
Latest FDA and cGMP Compliance News In 2011, FDA did a careful analysis of all 510(k) data to figure out what was causing medical device review times to increase. In this study, FDA found six problems related to the quality of 510(k) submissions. If your application has any of these problems, you are probably going […]
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Essential Tips for New FDA 510(k) Refuse to Accept Policy
Latest FDA and cGMP Compliance News FDA recently revised its Refuse to Accept policy for all 510(k) applications that did not have all required documentation. All device manufacturers that want to go through the premarket notification process should get to know all of the steps that are need to get their 510(k) application done and […]
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Absolute Worst FDA Warning Letter Responses
Has your company received an FDA warning letter? Please do not make a bad situation worse by engaging in any of these terrible FDA warning letter response mistakes! #1 Give a Late Warning Letter Response It’s old news now, but many people still do not remember that you now have only 15 days to respond […]
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