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Laboratory Safety: FDA Should Strengthen Efforts to Provide Effective Oversight

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Report Type Reports and Testimonies
Report Date Sept. 8, 2020
Release Date Oct. 8, 2020
Report No. GAO-20-594
Summary:

In 2017, the Food and Drug Administration created a new office within the agency to oversee its lab safety program. But, 3 years later, there are still disagreements within the FDA about the office's roles and responsibilities.

Moreover, FDA's lab safety program does not include key elements of effective oversight. For example, lab safety office staff cannot inspect labs unannounced. Unannounced inspections can help to better observe a lab's normal operating conditions.

We recommended that the FDA resolve disagreements over the office's roles and responsibilities and provide it with the authority to oversee lab safety.

Entrance sign for the Food and Drug Administration building

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