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williamxiang

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Directed and For Cause inspections may be initiated at both home districts' and headquarters' direction. These are priority inspections that are likely to be application/product specific. They can be referred from review divisions, forensic testing laboratories (based upon analysis of previously collected forensic samples) or result from CDER market surveillance or district surveillance, etc. Headquarter assignments will be coordinated and issued by HFD-324. A copy of the district-initiated "directed" or "for cause"  assignment should be forwarded to HFD-324 at the time of issuance.

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