You May Not Even Know You are on Import Alert
April 8, 2013 So your drug company has some serious cGMP guideline violations. Were you aware that FDA will not necessarily tell you if your pharmaceutical company has been placed on import alert? It happens. In some cases, an importer may have gotten the product from a third country, or from a shipper not allowed […]
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How to Ensure FDA cGMP Compliance With Employees
April 5, 2013 We frequently hear from QA managers who talk about innovative ways to keep employees focused on cGMP regulations and to help all workers to understand their vital importance in modern drug production. There is no doubt that regular cGMP training can help to keep employees well trained on FDA compliance. But most […]
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cGMP Inspection Tip – Best and Worst 483 Response Letters
More Exclusive FDA and cGMP News! April 4, 2013 So, you had a cGMP FDA inspection, and you got a 483 with some cGMP guidelines violations. What is a good and a bad response letter to that 483? First of all, remember that the 483 is just a preliminary observation report from the FDA investigator. […]
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Beware of Repeat 483 Violations
Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 4, 2013 We came across this week a warning letter dated March 18, 2013, issued by FDA to Keystone Laboratories in Bozeman, Montana. This cosmetics manufacturer was cited for a number of fairly significant GMP violations. The company didn’t maintain its […]
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Bugs and More Bugs – An FDA cGMP Inspection Disaster
April 3, 2013 We came across a recent warning letter issued by FDA to an API supplier in Japan called Asada Milling. We would like you to take note if you have any drug products in your home that contains anything handled by this firm. Why, you ask? Because the list of FDA cGMP violations […]
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Harsh FDA Social Media Enforcement – Not Really, Report Finds
Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 3, 2013 A new report by the Eye on FDA blog has published an interesting report that attempts to assess the regulatory actions of FDA’s Office of Prescription Drug Promotion that were due to the increased usage of digital and social […]
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3 Tips to Handle Non-PDF Files in Your FDA eCopy Submission
April 3, 2013 Most people know that you can provide PDF files with your electronic eCopy submission (some hints on that here). However, the guidance points out that you also can create an eCopy that has files that are not PDFs. This is done by including Statistical Data or MISC Files folder at the root […]
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4 Tips for Pharma in Social Media from Former FDA Commissioner
April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission April 2, 2013 Questions remain regarding social media use in pharma According to Peter Pitts, a former associate commissioner at FDA, there are a number of things that the pharmaceutical industry needs to learn in using social media. We […]
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More Clarity Needed on FDA eSource Trial Data Draft Guidance
April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance April 1, 2013 There are numerous calls among clinical trial stakeholders for more clarity on FDA draft guidance that tries to reduce pitfalls in switching to electronic source data for future clinical investigations. Hospira Consent Decree Coming? The draft […]
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FDA/Customs Country of Origin Confusion on Drug Imports
Learn About PREDICT – FDA’s New Import Screening Program April 1, 2013 When drugs are imported into the US, there is a lot of information that needs to be reported to US Customs and to FDA. The information is collected and transmitted by computer, usually done by the importing company’s designated broker. One of the […]
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