FDA Inspectional Approach, Paul Bellamy (733 KB)
FDA Inspectional Approach, Paul Bellamy (733 KB)
FDA Inspectional Approach, Paul Bellamy (733 KB)
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<strong>FDA</strong>-483 INSPECTIONAL<br />
OBSERVATIONS<br />
• SHOULD INCLUDE LOT NUMBER AND<br />
RELATE TO PRODUCT ON THE MARKET.<br />
IF NOT, WHAT IS THE SIGNIFICANCE?<br />
ROLE OF <strong>FDA</strong> IS TO PROTECT THE<br />
PUBLIC<br />
• MAKE SURE OBSERVATIONS ARE<br />
FACTUALLY CORRECT?<br />
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