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# Corporate Compliance Guidance Tracks GMP: Attorney
- URL: https://www.fdaweb.com/corporate-compliance-guidance-tracks-gmp-attorney/
- Published: 2019-05-02T12:00:00.000Z
- Updated: 2026-09-15T01:24:11.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5144014

An updated Justice Department guidance document reinforces the importance of a robust, well-designed, and effective corporate compliance program in the department’s determination of whether to prosecute, impose monetary penalties, and require compliance obligations on a company accused of misconduct. Attorney **Anne Walsh** (Hyman, Phelps & McNamara) [writes](http://www.fdalawblog.net/2019/05/doj-guidance-for-corporate-compliance-programs-parallels-gmp-requirements-for-drug-and-device-companies/?utm%5Fsource=feedburner&utm%5Fmedium=email&utm%5Fcampaign=Feed%3A+FdaLawBlog+%28FDA+Law+Blog%29) in her firm’s *FDA Law Blog* that the guidance expands on the types of questions prosecutors should be asking to evaluate a company’s compliance program.

Questions are in these three main categories, she says: **(1)** is the compliance program well designed; **(2)** is the program being applied earnestly and in good faith (implemented effectively); and **(3)** does the compliance program work in practice.

“Notably,” Walsh writes, “these same questions are those that drug and device companies routinely ask in the context of evaluating complaints about the company’s products. The Quality System Regulation requires medical device companies to establish procedures to implement corrective and preventive action. These procedures must include an investigation of the cause of the issue, actions to correct and prevent recurrence of the issue, validation to ensure the actions are effective, and management oversight and review. Similar requirements are imposed on drug manufacturers as part of complaint handling and adverse event reporting. Thus, a framework for addressing compliance issues should be very familiar to pharma and device companies.”