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
Audit Requested United States Single-Use Systems Pall Biotech Fajardo, Puerto Rico August 10, 2021 TBD…
JA-1117 Germany Excipient Merck Darmstadt July 19-20, 2021 Isopropylic Alcohol Glycerin Sodium Hydroxide…
JA-2499 United States Single-Use Systems MilliporeSigma (Merck KGaA) - formerly EMD Millipore Jaffrey, NH June 15-16, 2021 TBD…
JA-2513 Europe API/Excipient Pharmacosmos Holbaek, Denmark June 8-9, 2021 TBD…
JA-1179 Japan API/Excipient Ajinomoto Kawasaki-Ku June 3-4, 2021 Levodopa, Phenylalanine, Tyrosine, Aspartic acid,…
JA-1180 United States Packaging Healthcare Packaging (Airnov) Belen, NM April 21,, 2021 Desiccants, Packets & Canisters…
JA-1142 Spain Excipients/API/Basic Chem/Raw Materials Merck SLU Poligono Merck 08100 Mollet del Valles, Barcelona April 7-8, 2021 TBD…
Audit Requested Austria Basic Chem/Raw Material Cytiva, formerly part of GE Healthcare Life Sciences Pasching TBD 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 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 (July-Sept 2021) TBD…
JA-2553 Israel Single-Use Systems Sartorius Biological Industries Israel Beit Haemek Ltd Beit Haemek TBD (June/July 2021) TBD…
Audit Requested Singapore Basic Chemicals/Raw Materials Cytiva, formerly part of GE Healthcare Life Sciences Singapore TBD TBD…
JA-2550 United States Single-Use Systems Pall Biotech Duncan, South Carolina TBD (late July/early August 2021) TBD…
Audit Requested Netherlands Single-Use Systems Pall Biotech Medistadt BV Medemblik, Netherlands TBD (Q3 2021) TBD…
Audit Requested United Kingdom Single-Use Systems Pall Biotech Illfracombe, United Kingdom TBD (Q4 2021) TBD…
Audit Requested Belgium Single-Use Systems Pall Biotech Hoegaarden TBD (Q1 2022) TBD…
JA-2562 India Single-Use Systems Sartorius Stedim Bangalore TBD (week of June 14, 2021) Manufacturing of Fermentors, Bioreactors, Single…
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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