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Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
aff in the field who work for the FDAs Office of Regulatory Affairs (. Recommendations from field investigators are an important factor in the evaluation and classification process, but we also consider other important factors: the manufacturers prior inspection history; how issues identified during the investigation relate to the quality and safety of drugs being produced; the manufacturers response to the inspectional findings, including any proposed corrective actions by the manufacturer; and

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