Browsing Category Compliance Tips

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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Category : Compliance Tips

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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Category : Compliance Tips

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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Category : Compliance Tips

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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Category : Compliance Tips &News

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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Category : Compliance Tips &News

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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Category : Compliance Tips

Free FDA Compliance and cGMP Reports

Below are a number of free reports, articles and white papers on FDA compliance and cGMP guidelines. This list was updated in April 2013, and we add to it often, so please check back. Also, be sure to read our latest cGMP and FDA compliance news – updated daily. Bottom Line for FDA Compliance – [...]

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Category : Compliance Tips

5 Tips for Rock Solid Supplier Controls

Updated Daily – Read our latest FDA, cGMP Compliance News Are you in control of your medical device chain of supply to ensure quality? Here are five simple tips to help you to obtain better supplier control for the benefit of your patients, practitioners and employees: #1 Set Up Product/Service Quality Requirements During Design of [...]

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Category : Compliance Tips

More Counterfeit Drugs Pop Up – What to Do?

Updated Daily – Read our latest FDA, cGMP Compliance News Congress is currently mulling over a bill to provide better security to the drug supply, but we are seeing reports of still more counterfeit drugs coming onto the market. The latest is regarding an FDA alert about fake Botox, with the labels on the vials [...]

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Category : Compliance Tips &News

How to Optimize Your Quality System To Ensure FDA and ISO Compliance

Updated Daily – Read our latest FDA, cGMP Compliance News So what does cGMP quality cost? Many pharmaceutical companies would have a hard time defining quality in terms of dollars. However, what everyone DOES know is that poor quality can cost you millions in terms of a warning letter clean up or even a consent [...]

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Category : Compliance Tips

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