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 Simone Ziss at sziss@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
JA-1180 United States Packaging Healthcare Packaging (Airnov) Belen, NM April 21,, 2021 Desiccants, Packets & Canisters…
JA-1117 Germany Excipient Merck Darmstadt April 19-20, 2021 Isopropylic Alcohol Glycerin Sodium Hydroxide…
JA-1142 Spain Excipients/API/Basic Chem/Raw Materials Merck SLU Poligono Merck 08100 Mollet del Valles, Barcelona April 7-8, 2021 TBD…
JA-1175 USA Single-Use Systems Sartorius Stedim North America, formerly Allpure Technologies LLC New Oxford, PA March 23-24, 2021  Takeone®  Quickseal®  Mycap® and…
JA-1116 Switzerland Single Use Sartorius Stedim Switzerland AG Tagelswangen March 10-11, 2021 Single use components…
JA-1114 France Single Use Sartorius Stedim Aseptics SAS Lourdes February 23-24, 2021 Single use components…
JA-1156 USA API Ajinomoto Co, Inc. Raleigh Feb 16-17, 2021 APIs…
JA-1166 United States Single-Use Systems/Basic Chemical/Raw Materials MilliporeSigma (Merck KGaA) - formerly EMD Millipore Danvers, MA Feb 10, 2021 Cleanroom Facility; BPC; Filters…
JA-1172 Japan Excipient/Basic Chemicals/Raw Materials Ajinomoto Saga-Gun Feb 3-4, 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…
Audit Requested Austria Basic Chem/Raw Material Cytiva, formerly part of GE Healthcare Life Sciences Pasching TBD Q1 2021 Cell Culture Dry Powder Media…
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 date TBD 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 maybe June 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 United Kingdom TBD Sartorius Stedim BioOutsource Ltd. Glasgow TBD 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 TBD TBD…
Audit # Region Standards Company Location Date Materials

Interested in submitting a new audit request through the Rx-360 Audit Program? Contact us today.







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