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Form / Diluent / Fagan inspection / Validation / Inspection / Vaccine / Quality / Evaluation / Management


Review Memo – Response to CR Letter for Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine.
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Company

GlaxoSmithKline Biologicals / negatively impacting the GSK / /

Country

United States / Belgium / /

Event

FDA Phase / Product Issues / /

Facility

Belgium facility / /

IndustryTerm

vaccine manufacturing process / manufacturing / /

Organization

FDA / /

Person

Carolyn Renshaw / Sean Byrd / /

Position

Major / inspector / Chief / /

Product

Biologics / MenHibrix ® / containers / /

Technology

simulation / /

SocialTag