When observations are identified during an inspection, it is FDA’s expectation that a firm will remediate the issues. This expectation is even more important if a firm receives a warning letter. Lupin Limited (India) seems to have come up short on both accounts.
Over the years, the FDAzilla blog has published over 650 articles. We hope this compilation will serve as a resource for you and your company. It should also help orient you to the scope of the FDAzilla blog as you continue to follow our efforts to provide accessible FDA data and insights.
GMP/GCP compliance failures in the drug product segment are no longer identified as the ‘software not being validated for its intended use’, but rather the deficiencies are now linked to the predicate GMP requirements based on FDA’s stated focus in 2010.
GMP expert Barbara W. Unger analyzes the major initiatives put forth in CDER’s Office of Compliance Annual Report for CY2018.
The second and final part of this report will cover the actions firms can take to prevent, identify, and remediate issues as well as summarizing the trends of data integrity failures.
GMP expert Barbara W. Unger evaluates data integrity deficiencies from CY2018 and presents the trends since CY2008.
GMP expert Barbara W. Unger reviews the Office of Generic Drugs’ 2018 Annual Report.
Does the FDA cite the same data integrity keywords on warning letters as 483s? Not really.
Part two of this series will walk through our tagging methodologies and analysis on data integrity keyword 483 citations over the last five years.