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•Article: Trends In FDA Violations

By Michael Gregor

An increase of federal FDA investigators has led to an elevated level of inspections across the United States and abroad. Consequently, there has been an array of new violations as well as repeat violations. Repeat violations result in the formation of industry trends and can be quite alarming when you consider that different areas of the country and world are making the same mistakes.

Some of the new violations I am seeing that have not been prevalent in the past are violations for the lack of computer system validation on quality system software as well as software embedded inside devices.

Used with permission from Life Science Leader magazine.

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•Article: Trends In FDA Violations