Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
other factors that may arise. Final decisions about what action to take based on an inspections findings reflect a careful analysis of all relevant information.

In the great majority of cases, (about 75 percent of the proposed surveillance inspection classifications from the field), experts in CDER concur with the inspection classification recommendation from the field investigators. Per the agreed upon process and procedure, CDER makes the final decision regarding the issuance of warning lett

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