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.

Please note that we are transitioning to a brand new upgraded auditsPLUS database, we appreciate your understanding and patience during this transition. We want to make sure that there is no interruption in our service and your needs. If you are interested in scheduling an audit or are interested in knowing what audits are open for co-sponsorship please contact:

Jaye Greene: Head of Audit Operations and Quality jgreene@rx-360.org
Simone Ziss: sziss@rx-360.org

Audit # Region Standards Company Location Date Materials
JA-2625 Italy API's Menarini Biotech Rome Sept 13-16, 2021 anti-SARS-CoV-2 monoclonal antibody…
JA-2472 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) …
JA-2478 USA Single Use/Basic Chemcial ELDON JAMES CORP in DENVER, United States Denver TBD 2021 Consumables, Process Aids, reduction…
JA-2458 USA 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…
JA-1131 United States Packaging/Single Use System Nalge Nunc Intl Rochester, NY TBD polypropylene bottle clearboy, polycarbonate tank…
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…
JA-2553 Israel Single-Use Systems Sartorius Biological Industries Israel Beit Haemek Ltd Beit Haemek November 2021 (date TBD) o Cell Culture Media R&D &…
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 (November/December 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…
JA-2580 China API's Hovione Taipa, Macau TBD Oct/Nov 2021 Doxycycline Hyclate (non-sterile API) ,…
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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