I am doing Masters in regulatory affairs from Northeastern university, Boston.

Hi,

I am doing Masters in regulatory affairs from Northeastern university, Boston.

The current course I am enrolled in to is RGA6370 Advanced Regulatory Writing Medical Device Submissions.

Please see below the week 1 assignment question.

Identify in each FDA Warning letter (links below) the company name, date and summarize the deficiencies and explain what you would do to correct the issue and to prevent a recurrence. Use PPT or Word (length roughly equal to one WORD page per warning letter)

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fresenius-kabi-ag-671249-01042024Links to an external site.https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/royal-philips-676605-02232024Links to an external site.https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/irhythm-technologies-inc-643474-05252023Links to an external site.https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/outset-medical-inc-656485-07052023Links to an external site.