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Who's that knocking at the door? Preparing for an FDA inspection

Businesses that manufacture FDA-regulated products are not the only ones that can be inspected by the U.S. Food & Drug Administration at any time. FDA also inspects clinical trial sites (studies in humans) and nonclinical laboratories that conduct animal, plant or microorganism studies used in FDA applications for drugs, biologics, or devices.

FDA enforces ......

Full article >>> examining equipment, reviewing documents, collecting product samples, and interviewing employees.

At the end of the inspection, if the investigator believes conditions deviate from FDA requirements or violative products exist, the investigator will issue a notice of inspectional observations (called a Form 483). The investigator will review the 483 and each observation with management-lev......

Full article >>> d follow-up and response procedures after the inspection ends.

Mock Inspections. Although a mock inspection cannot fully prepare one for the real thing, a simulated inspection helps identify possible weaknesses in the SOPs and provides personnel with a better appreciation of both the questions that they may be asked and the seriousness of the inspection process.

Regular re......

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Source:wistechnology.com By Patricia Kaeding 07/12/05


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