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-2513 Europe API/Excipient Pharmacosmos Holbaek, Denmark August 23-24, 2021 API: • DEXTRAN 70 Excipient: •…
JA-1178 United States Single-Use Systems Pall Biotech Fajardo, Puerto Rico August 10, 2021 TBD…
JA-2563 United Kingdom TBD Sartorius Stedim TAP Royston, England July 29-30, 2021 TBD…
JA-1117 Germany Excipient Merck Darmstadt July 19-20, 2021 Isopropylic Alcohol Glycerin Sodium Hydroxide…
JA-2518 United States Single-Use Systems Saint Gobain Performance Plastics Gaithersburg, MD July 19-20, 2021 KryoSure, VueLife, fluid transfer assemblies,…
JA-1179 Japan API/Excipient Ajinomoto Kawasaki-Ku June 3-4, 2021 Levodopa, Phenylalanine, Tyrosine, Aspartic acid,…
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-2564 United Kingdom TBD Sartorius Stedim BioOutsource Ltd. Glasgow TBD (July-Sept 2021) TBD…
JA-2580 China API's Hovione Taipa, Macau TBD Oct/Nov 2021 Doxycycline Hyclate (non-sterile API) ,…
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-2604 United States ISO 13485 BioLife Solutions Bothell, WA July 13, 2021 (remote) HypoThermosol; CryoStor…
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) …
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…
JA-2550 United States Single-Use Systems Pall Biotech Duncan, South Carolina TBD (October/November 2021) TBD…
Audit Requested US Packaging CCL Labels St. Charles TBD Labels, booklets, booklet carton, booklet…
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-1151 Denmark API BASF A/S Ballerup Postponed date TBD Retinyl Palmitate (Vitamin E) Vitamin…
Audit Requested Belgium Single-Use Systems Pall Biotech Hoegaarden TBD (Q1 2022) TBD…
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 France Basic Chemicals/Raw Materials Lasaffre Ingredients Services (Procelys/Biospringer) Cerences TBD Yeast Extract…
JA-2540 United States Packaging Corning Kennebunk, Maine Rescheduling Date TBD (was July 19-20, 2021) TBD…
Audit # Region Standards Company Location Date Materials

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







    Menu