Compliance Tips

  • How to Handle An FDA Warning Letter

    Did your company receive an FDA warning letter, possibly including cGMP violations? If so, there are vital steps you can take to reduce the effects of the warning letter. The warning letter will be issued if there is a deficiency or violation in your pharmaceutical or medical device... Read More »

  • FDA Talks About Importance of Data Integrity And Data Governance Plans

    At the recent PDA/FDA Joint Regulatory Conference, CDER's Quallyna Porte talked about how FDA is focusing on data integrity and data governance plans in 2022 cGMP audits. Porte noted that pharmaceutical companies need a solid data governance plan that is as well established as possible. This... Read More »

  • FDA Stresses The Importance Of Engaging With The Agency Early and Formally

    In February 2022, FDA organized a public oncologic drugs advisory committee or ODAC meeting to review a sintilimab application that was based on the ORIENT-11 clinical trial done in China only. Instead of following the regular method of reviewing the risks and benefits of one drug, the FDA... Read More »

  • Is Your cGMP Quality System Ready For An FDA Inspection?

    At this year's PDA/FDA conference, FDA's Director for the Division of International Drug Quality Carmelo Rosa offered the agency's regulatory point of view on pharmaceutical quality systems. She also detailed some of the latest FDA audit trends of drug facilities. Rosa noted as she reviewed... Read More »

  • Most Common FDA 483 Inspection Observations in 2020

    By reviewing the most common FDA 483 inspection observations, it's possible for pharmaceutical companies to get a better grasp of how to organize their facility procedures and personnel. We recently came across FDA data that revealed some of the most common 483 observations for 2020:... Read More »

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