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Pharmaceutical sciences / Health / Food and Drug Administration / LASIK / Validity / Form FDA 483 / Medical device / Verification and validation / Good manufacturing practice / Medicine / Food safety / Pharmaceutical industry


Refractive Manufacturing Operations, Warning Letter
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Document Date: 2008-02-11 14:21:53

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File Size: 44,41 KB

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City

Orlando / Maitland / Discovery Drive Orlando / /

Country

United States / /

Event

Product Issues / /

IndustryTerm

quality assurance systems / gas filters / laser control electronics / manufacturing / subject devices / /

MedicalCondition

headache / nausea / seizure / vomiting / serious injury / injury / serious injuries / /

MedicalTreatment

retreatment / surgery / /

Organization

Food and Drug Administration / FDA / FDA Department of Health / /

Person

Emma R . Singleton / Timothy J. Couzins / /

/

Position

Investigator / Field Service Engineer / Compliance Officer / Translator / malfunctioning translator / Vice President Refractive Manufacturing Operations Alcon Laboratories / Director / Florida District FOI Home Page / Manufacturing Engineer / Woodrell Vice President / /

Product

pre-op / bearings / /

ProgrammingLanguage

FL / /

ProvinceOrState

Florida District / Florida / /

Technology

laser / DSP / Laser System / /

URL

http /

SocialTag