| Document Date: 2012-06-13 09:01:28
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City GENEVA / Hengdian Town / Dongyang / / Company COMPLAINTS AND / Levofloxacin (APIMF099) Ofloxacin (API for FPP) Production / Hengdian Group / Zhejiang Apeloa Kangyu Pharmaceutical Co. Ltd. / / Country Switzerland / China / / / Event Product Issues / Person Communication and Meetings / Product Recall / / Facility QC laboratory / LABORATORY CONTROLS General Controls The / / IndustryTerm operational qualification protocols / internal audit / media sterilization / cephalosporin solid dosage forms manufacturing workshop / media preparation / batch manufacturing records / utility systems / manufacturing performance / manufacturing activity / product processing / manufacturing steps / validation protocols / manufacturing equipment / inspected manufacturing facilities / air exhaust purification equipment / manufacturing / selected batch manufacturing record / active pharmaceutical ingredients / pharmaceutical products / manufacturing procedures / gas pipelines / utilities etc / / Organization World Health Organization / Manufacturer Unit / FDA / QC Department / / Person Chen / / / Position LABORATORY CONTROLS General / General information Name / Summary General / QA manager / general Quality Assurance / / Product Levofloxacin / Ofloxacin / The standard operating procedure / CH-1211 GENEVA / also inspected regarding the Ofloxacin / / ProvinceOrState Quebec / / Technology ion exchange / API / validation protocols / operational qualification protocols / / URL WWW.WHO.INT / /
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20, AVENUE APPIA – CH-1211 GENEVA 27 –SWITZERLAND – TEL CENTRAL +[removed] – FAX CENTRAL +[removed] –WWW.WHO.INT WHO PUBLIC INSPECTION REPORT (WHOPIR) API Manufacturer Part 1: General information