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A cross-sectional study of USFDA warning letters issued for cGMP violations pertaining to medical devices

Kavyashree, Praveen Hiremath, Francis Fernandes, Pradeep Muragundi.

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Aim of the study is to carry out a cross sectional study of warning letters issued by USFDA for cGMP violations in order to understand the common types of violations for medical devices. Publicly available USFDA letters issued from January 2008 to July 2018 have been manually screened based on the letter's subject and content. Overall, 669 warning letters issued for medical device cGMP violations were reviewed. The number of warning letters issued in 2014 was 101, followed by 106 in 2015, as the USFDA focused more on data integrity issues, while the number decreased to 53, 27 and 19 respectively in 2016, 2017 and 2018. Highest number of warning letters were issued to manufacturers located in USA (379) followed by Canada (52) and China (37). Section 820.30 of Title 21 CFR was found to be most violated with 603 infringements. With the time, scientific developments and increased awareness of both regulatory authorities and industries/academic organizations, overall improvement observed with the significant decrease in number of warning letters.

Key words: USFDA Warning letters; Medical devices; cGMP violations; Data Integrity

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