This is a list of the audits that we either have scheduled (will show a “JA#” and a firm date), or the audit request has been accepted by the auditee (will show “Audit Requested” and/or a TBD date).

If you are interested in co-sponsoring one of these audits, or initiating a new audit, please contact Hannah Song at hsong@rx-360.org.

Note: After these audits are completed and the report is finalized, the audit detail will move from this page to the Licensable Audit Reports page, and the report will be available for licensing.

Audit # Region Standards Company Location Date Materials
Audit Requested Germany Basic Chemicals/Raw Materials Albemarle Langelsheim May 2021 TBD…
JA-1117 Germany Excipient Merck Darmstadt April 19-20, 2021 Isopropylic Alcohol Glycerin Sodium Hydroxide…
Audit Requested Denmark Excipients Dansk Salt A/S (formerly known as Akzo Nobel Salt A/S) Mariager April 14-15, 2021 TBD…
Audit Requested USA Basic Chem/Raw Material MilliporeSigma (Merck KGaA) - formerly EMD Millipore Temecula, CA March 16-17, 2021 GENETICIN, Sterile WFI Cell Culture…
Audit Requested Spain Excipients/API/Basic Chem/Raw Materials Merck SLU Poligono Merck 08100 Mollet del Valles, Barcelona March 16-17, 2021 TBD…
JA-1116 Switzerland Single Use Sartorius Stedim Switzerland AG Tagelswangen Feb 24-25, 2021 Single use components…
Audit Requested US API Ajinomoto Co, Inc. Raleigh Feb 16-17, 2021 APIs…
Audit Requested Japan Excipient/Raw Material Ajinomoto Saga-Gun Feb 2-4, 2021 Amino acids, etc…
JA-1144 United States Basic Chem/Raw Material Cytiva, formerly part of GE Healthcare Life Sciences Westborough, MA Jan 27-28, 2021 Hollow Fiber Cartridges Bag Assemblies…
JA-1127 Japan Basic Chem/Raw Material Asahi Kasei Medical Oita city Dec 17, 2020 Sterile Cartridge Planova, Filter Planova,…
JA-1157 New Zealand Basic Chem/Raw Material Cytiva, formerly part of GE Healthcare Life Sciences (Hyclone) Tauranga Dec 17, 2020 Fetal Bovine Serum, etc…
Audit Requested Japan Basic Chem/Raw Material Asahi Kasei Medical Nobeoka Dec 15-16, 2020 Sterile Cartridge Planova, etc…
JA-1158 Singapore Packaging West Pharmaceutical Services, Inc. 15 Joo Koon Circle December 10, 2020 Vial Plugs…
JA-1132 Germany Packaging Schott Pharmaceutical Mulheim December 3, 2020 Vials…
JA-1162 China Basic Chem/Raw Material Merck KGaA (MilliporeSigma in N.A.) Nantong November 30-December 2, 2020 Sodium Acetate Trihydrate, Sodium Sulfate,…
JA-1165 Canada Basic Chemicals/Raw Materials Jungbunzlauer Port Colborne, Ontario Nov 24-25, 2020 • Citric Acid Anhydrous • Trisodium Citrate Dihydrate • Tripotassium…
JA-1139 US Excipient/Raw Material Avantor Performance Materials Paris, KY November 18-19, 2020 Sodium chloride, multi-compendial Sodium Phosphate…
JA-1114 France Single Use Sartorius Stedim Aseptics SAS Lourdes TBD - Jan/Feb 2021 Single use components…
Audit Requested Austria Basic Chem/Raw Material Cytiva, formerly part of GE Healthcare Life Sciences Pasching TBD Q1 2021 Cell Culture Dry Powder Media…
JA-1125 USA Excipient Archer Daniels Midland Southport, NC TBD Citric Acid Anhydrous…
Audit Requested Japan Packaging Daikyo Seiko Sano-shi Q1 2021 rubber stopper, etc…
JA-1122 Germany Basic Chem/Raw Material CellGenix Freiburg im Breisgau TBD Interleuken-2 (IL-2) …
Audit Requested US Excipient Sensient colors St Louis TBD Yellow Iron Oxide, Siena Iron…
Audit Requested USA Single Use/Basic Chemcial ELDON JAMES CORP in DENVER, United States Denver TBD Consumables, Process Aids, reduction…
Audit Requested US API/Basic Chemical Archer Daniels Midland  Decatur TBD Sorbitol Solution, D-alpha Tocopherol, etc.…
Audit Requested US API/Excipient SpecGx (Mallinckrodt) St Louis TBD Sodium Acetate, MG Stearate Nonbovine,…
Audit Requested US Packaging Berry global Baltimore TBD Caps…
Audit Requested US Packaging CCL Labels St. Charles TBD Labels, booklets, booklet carton, booklet…
JA-1151 Denmark API BASF A/S Ballerup Postponed (original dates November 17-18, 2020) Retinyl Palmitate (Vitamin E) Vitamin…
Audit Requested China Basic Chem/Raw Material Merck KGaA (MilliporeSigma in N.A.) Wuxi Q1 2021 TBD…
Audit Requested Sweden Excipient Nouryon (AkzoNobel) Bohus TBD Sodium Hydroxide Pellets…
Audit Requested United States Single-Use Systems MilliporeSigma (Merck KGaA) - formerly EMD Millipore Jaffrey, NH TBD May 2021 TBD…
Audit Requested United States Basic Chemicals/Raw Materials Biospringer North America Cedar Rapids, Iowa TBD Yeast Extract Spec Moisture …
JA-1131 United States Packaging/Single Use System Nalge Nunc Intl Rochester, NY TBD polypropylene bottle clearboy, polycarbonate tank…
Audit Requested France Basic Chemicals/Raw Materials Lasaffre Ingredients Services (Procelys/Biospringer) Cerences TBD Yeast Extract…
Audit Requested USA TBD Sartorius Stedim North America Hopkinton, MA TBD TBD…
Audit Requested United Kingdom TBD Sartorius Stedim Chromatography Systems Ltd Hampshire TBD TBD…
Audit Requested France TBD Sartorius Stedim Chromatography Resins S.A.S. Cergy TBD - Jan 2021 TBD…
Audit Requested United Kingdom TBD Sartorius Stedim BioOutsource Ltd. Glasgow TBD TBD…
Audit Requested USA TBD Sartorius Stedim North America, formerly Allpure Technologies LLC New Oxford, PA TBD - Feb 2021 TBD…
Audit Requested Israel TBD Sartorius Biological Industries Israel Beit Haemek Ltd Beit Haemek TBD TBD…
Audit Requested Singapore Basic Chemicals/Raw Materials Cytiva, formerly part of GE Healthcare Life Sciences Singapore Feb 4/5, 2021 TBD…
Audit # Region Standards Company Location Date Materials

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