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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Essential Tips for Bulletproof cGMP Quality Agreements
Updated Daily – Read our latest FDA, cGMP Compliance News Our webinar on quality agreements on May 1 was packed with really interesting tips on how to make sure your quality agreement is in fully cGMP compliance so you never get an FDA 483. The speaker, Alan Minsk, a partner for Arnall, Gold and Gregory […]
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Why So Few FDA Warning Letters?
Updated Daily – Read our latest FDA, cGMP Compliance News One of the favorite activities for some bloggers is to write about FDA warning letters and what sorts of patterns we can discern by the warning letters that are issued. If you look at some charts of the most recent warning letter activity, we do […]
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FDA Releases Ugly Novartis 483 for Lincoln NE Plant
Updated Daily – Read our latest FDA, cGMP Compliance News Novartis decided to give it up last week and announced that it was going to shrink drug manufacturing operations at its Lincoln, NE plant. They now only plan to make powder and solid products there, which include Excedrin headache pills, Theraflu, and Sentinel, which is […]
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Give Attention to Equipment Calibration Certificates
Updated Daily – Read our latest FDA, cGMP Compliance News FDA has noted recently that many medical device companies are not checking the quality of finished devices after learning that equipment was not calibrated properly. Many manufacturers contract out activities such as calibration. So, what can happen is that companies just accept calibration certificates from […]
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