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Medicine / Pharmaceutical industry / Form FDA 483 / Quality / Validation / Barrier isolator / Aseptic technique / Pharmaceutical sciences / Food and Drug Administration / Pharmacology


12 Applied CAPS Wallingford CT issued 483
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City

Manufacturer Wallingford / INSPECTED CITY / /

Company

Central Admixture Pharmacy Services Inc. / /

Currency

GBP / /

Event

Product Recall / Product Issues / /

Facility

i.e. warehouse / Pharmacy Servi / DURING THE INSPECTION OF YOUR FACILITY / /

IndustryTerm

final drug product / sterile pharmaceuticals / sterile injectable drug product / manufacturing area / manufactured drug products / media fills / sterile injectable drug products / manufacturing process / aseptic manufacturing operations / sterile drug products / representative container closure systems / aseptic processing rooms / sterile drug product / manufacturing areas / sterile injectable products / controlled manufacturing areas / manufacturing areas design / steri le drug products / classified manufacturing areas / /

MedicalCondition

sterility / hypoglycemia / result ofthis sterility / product sterility / /

MedicalTreatment

total parenteral nutrition / /

Organization

Dept of Health / FOOD AND DRUG ADMINISTRATION / DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DATE / Quality Unit / DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION OATE / FDA / DEPARTMENT OF HEALTH AND HUMAN SERVICES / DEPARTMENT OF HEALTH / /

Person

Maya M. Davis / Thomas W. Kelsey / W . Kelsey / Ramon E. Martinez / Philip Kreiter / Philip Kreite / /

/

Position

Investigator / Director of Operations FIRM NAME STREET ADDRESS / technician / Regional Director of Operations / Regional Director / REPRESENTATIVE / /

Product

notification / Sodium Chloride / Ropivicaine / Dextrose / TPN / Oxytocin / Prep Rooms / cardioplegic / notifications / Magnesium Sulfate / firm ' s cleaning procedures / sterile drug products / 7 areas / /

ProgrammingLanguage

RC / /

ProvinceOrState

SERVIC ES FOOD AND DRUG ADMINISTRATION DISTRICT / OF INSPECTION New England District / Connecticut / Nova Scotia / Massachusetts / /

PublishedMedium

the Technical bulletin / /

RadioStation

WHOM / /

Region

New England / /

URL

www.fda.gov/oc/industrv / www .fda.gov/octindustry / www.fda / www.fda.gov/odindustry / www.fda.gov/oc/industry / /

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