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OE PAK I MI:.NT Ugh H E ALTO AND HUMAN S SERVICES FOOD AND DRUG ADMIN IST RATION DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION Center for Food Safety and Applied Nutrition, Office
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During audit be confident, decent and polite. If personnel seem in-confident during the audit, a good auditor can guess it that can affect the overall audit performance. The attitude should be positive during the whole FDA inspection. Never try to show your knowledge to the inspector and challenge him.
“When asked a question by the investigator, answer only the question asked of you.” "If you don't know the answer to a question, don't guess. Inform the investigator that you don't know, but will find out for them.” “If an issue arises, don't attempt to quickly resolve it in front of the investigator.”
Risk analysis: Inspectors will want to see that you've put any and all appropriate risk monitoring systems in place and that you're routinely assessing relevant risks within your operations. Product recall and rejection reports. Equipment and instrumentation calibration and maintenance reports.
Be familiar with FDA regulations as applicable, FDA guidance documents, FDA guidance manuals for inspectors. Review previous warning letters from FDA, prior FDA 483s, prior establishment inspection reports (EIR). Relevant documents and records should also be reviewed and ensure that they are readily available.

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Dipesh Shah is a professional associated with the US Food and Drug Administration (FDA), but specific details about him or the context of 'dipesh shah usfda' are not widely available.
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The purpose is likely to facilitate regulatory compliance, promote public health and safety, or ensure that products meet FDA standards.
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