The US Food and Drug Administration (FDA) has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices (GMPs) related to the ...
Applied Therapeutics, a clinical-stage biopharmaceutical company, is under heightened scrutiny following the issuance of a November 2024 Warning Letter 1 from the US Food and Drug Administration (FDA) ...
The warning letter, issued on March 30 following a September 2025 inspection, says the company’s manufacturing practices have ...
The inability to conduct onsite inspections impeded investigators’ ability to uncover data integrity issues at manufacturing sites in drug warning letters in FY2021, underscoring the importance of ...
After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
The primary market opportunities lie in equipping professionals with practical skills for preparing, managing, and responding to FDA inspections. This training addresses common challenges and ...
Zydus Biologics' injectable plant in Ahmedabad received seven observations during a recent USFDA inspection, with no data ...
USFDA concludes inspection at Zydus Biologics'' Ahmedabad injectable plant with 7 observations. No data integrity issues noted.
The inspection closed with seven observations. Zydus Life said there were no data integrity-related observations and that it ...
Ramakrishna Sesham, Senior Manager at Astellas Pharma, develops enterprise data governance frameworks that reduce FDA ...
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