Category: Enforcement Trends

Enforcement Actions Against Sartan Manufacturers

Health authorities worldwide have overseen the recall of many ‘sartan’ products in the past few years.  These recalls began in the US as early as 2013 with a recall of product by Teva Pharmaceuticals. Here, we address some of the enforcement actions taken against a few of the notable players in this series of events.

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yellow pills

Repeat Deficiencies in Lupin Limited Warning Letters

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.

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Most Popular Blog Posts - Larger Font 720

FDAzilla’s Top 20 Posts of All Time

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.

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Software Validation

Identification of Software Validation Shortcomings

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.

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