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The guide was prepared by the Food and Drug Administration (FDA) Office of Regula- tory Affairs (ORA), and the Center for Devices and Radio- logical Health
25 Nov 2014 The Guide to Inspections of Quality Systems provides instructions for and Drug Administration (FDA) Office of Regulatory Affairs (ORA), and
These guidelines of ORA within FDA are not addressed to the industry but to the FDA inspectors. The Guides to Inspection are, however, a useful aid. Here you
Foreign Inspections - Guide to International Inspections and Travel information/policy on the management of Office of Regulatory Affairs (ORA) field activities.
25 Nov 2014 Guide to Inspections of Medical Device Manufacturers Office of Regulatory Affairs (ORA) and the Center for Devices and Radiological Health
25 Nov 2014 Consistency and uniformity of inspection and enforcement represent high priority goals for the Office of Regulatory Affairs (ORA). This guide
25 Nov 2014 ORA Inspectional References Guide to Inspections of Quality Systems is known as the "Quality System Inspection Technique" or "QSIT".
25 Nov 2014 This issuance launches the Inspectors Technical Guide, commonly Responsibility for ITG issuance rests with the *ORA/ORO/DEIO/HFC-130*.
We have recently redesigned the FDA Web Site. As a result, some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link
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