ABSTRACT

In recent time, the pharmaceutical industry, among others, has been markedly influenced by the COVID-19 pandemic. The current review article conducts a comprehensive analysis of USFDA warning letters and their impact on the pharmaceutical industry, making a comparison between the pre-COVID and post-COVID periods for Indian manufacturers. These warning letters serve as official notices of violations and errors found during inspections, requesting companies to correct them promptly. This analysis covers a range of factors, including non- compliance with Current Good Manufacturing Practices, quality control concerns, data integrity issues, product safety, packaging and labelling violations and also emphasizes the importance of addressing the new challenges arising from the pandemic and ensuring the resilience and safety of the pharmaceutical supply chain. Overall, this comprehensive examination of USFDA warning letters reveals the dynamic nature of regulatory compliance and the need for continuous evaluation and adaptation within the pharmaceutical industry. Keywords: United State Food and Drug Administration (USFDA), Warning letters, Inspection, pre-covid scenario, post-covid scenario, Out-of-specification
Publication date: 01/01/2025

https://ijbpas.com/pdf/2025/January/MS_IJBPAS_2025_8657.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.1.8657