483
AstraZeneca Pharmaceuticals, LPAstraZeneca Pharmaceuticals, LP – FDA 483, Jan 30, 2018
Record Details
AstraZeneca Pharmaceuticals, LP in Gaithersburg, MD, was inspected from January 25-30, 2018. The inspection revealed a significant compliance issue where the firm failed to report all serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days. This indicates deficiencies in their pharmacovigilance reporting processes.
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ID · 802dcb0f-4c3f-4e36-b64f-e85ed202036f
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