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Document Date: 2012-10-19 07:34:54


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File Size: 299,42 KB

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City

Liverpool / Walldorf / East Falmouth / /

Company

RAC Corporate Headquarters Associates / UK Office Associates / Corporate Headquarters Associates / Cape Cod Inc. / European Office Pyroquant Diagnostik GmbH / /

Country

Germany / United Kingdom / /

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Event

Product Issues / FDA Phase / Product Recall / /

Facility

Laboratory Diposibles / Laboratory Validation / /

IndustryTerm

rinse/extract solution / biological products / surgical site / finished pharmaceuticals / drug product / study protocol / biological product / larger medical devices / particular product / risk management / aqueous-based pharmaceuticals / manufacturing practice / physical and chemical properties / veterinary product / manufacturing processes / manufacturing process / in-process device / subsequent product / large devices / reagent transfer protocol / manufacturing environment / administered products / manufacturing design / manufacturing / implanted devices / comparability protocol / certain biological products / therapeutic drug products / drug products / guidance Web page / manufacturing procedures / device rinsing protocol / /

MusicGroup

Yes / /

Organization

Bacterial Endotoxins Test / 2 USP Chapter / office of Compliance / USP General Chapter / office of Regulatory Affairs / Center for Drug / Association for the Advancement / Center for Veterinary Pharmaceutical Production / Center for Devices / USP Chapter / Center for Devices and Radiological Health / Radiological Health / Association for the Advancement of Medical Instrumentation / Division of Manufacturing / FDA’s Center for Veterinary Medicine / FDA / European Union / Drug Administration / Photometric Quantitative Techniques / and USP Chapter / /

Person

Michael Dawson / /

/

Position

Editor / General / representative / /

Product

guideline document / former guidance documents / Guidance / guidance documents / Federal Food / PMA / animal drug / /

ProvinceOrState

Massachusetts / /

Technology

study protocol / comparability protocol / process control / pdf / reagent transfer protocol / device rinsing protocol / /

URL

www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM310098.pdf / http /

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