Audit Queue

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

If you are interested co-sponsoring one of these audits, or initiate any 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 Denmark Excipients Dansk Salt A/S (formerly known as Akzo Nobel Salt A/S) Mariager April 14-15, 2021 TBD…
Audit Requested Spain Excipients/API/Basic Chem/Raw Materials Merck SLU Poligono Merck 08100 Mollet del Valles, Barcelona March 16-17, 2021 TBD…
Audit Requested US Basic Chem/Raw Material MilliporeSigma (Merck KGaA) - formerly EMD Millipore Deptford, NJ March 9-10, 2021 GENETICIN, Sterile WFI Cell Culture…
Audit Requested US API Ajinomoto Co, Inc. Raleigh Feb 16-17, 2021 APIs…
Audit Requested 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 France API Evonik Rexim S.A.S. Ham Nov 24th, 2020 APIs…
Audit Requested US Excipient/Raw Material Avantor Performance Materials Paris, KY November 18, 2020 Sodium chloride, multi-compendial Sodium Phosphate…
Audit Requested Germany Packaging Schott Pharmaceutical Mulheim November 2020 Vials…
Audit Requested US API/Excipient Avantor Performance Materials Phillipsburg, NJ October 28, 2020 SODIUM ACETATE, HYDROUS USP POTASSIUM…
Audit Requested New Zealand Basic Chem/Raw Material Cytiva, formerly part of GE Healthcare Life Sciences (Hyclone) Tauranga October 20, 2020 Fetal Bovine Serum, etc…
Audit Requested France Single Use Merck KGaA (MilliporeSigma in N.A.) Molsheim Oct 13-14, 2020 single use components…
JA-1122 US Packaging West Pharmaceutical Services Jersey shore, PA Oct 8th, 2020 Stoppers…
JA-1116 Switzerland Single Use Sartorius Stedim Switzerland AG Tagelswangen Oct 2020 Single use components…
JA-1114 France Single Use Sartorius Stedim Aseptics SAS Lourdes Oct 2020 Single use components…
Audit Requested US Single Use MilliporeSigma (Merck KGaA) - formerly EMD Millipore Danvers September 22-23, 2020 Single use components…
Audit Requested Denmark API BASF A/S Ballerup Sept 15-16, 2020 Retinyl Palmitate (Vitamin E) Vitamin…
JA-1141 US Basic Chem/Raw Material Corning Inc Oneonta Sep 8th and 9th, 2020 Various cell culture flasks, erlenmeyer…
JA-1110 Portugal Excipient/API Hovione Loures Sept 3-4, 2020 Captisol, Minocycline hydrochloride …
Audit Requested United Kingdom TBD Sartorius Stedim Stonehouse August 11-12, 2020 TBD…
JA-1135 United States Single-Use Systems Colder Products Co. Roseville, MN Aug 10-11, 2020 Connectors…
JA-1131 United States Packaging/Single Use System Nalge Nunc Intl Rochester, NY Aug 6, 2020 polypropylene bottle clearboy, polycarbonate tank…
JA-1120 Germany Single Use Sartorius Stedim Plastics GmbH (SSP) Karl-Arnold Strasse, Goettingen August 2020 Injection/Assembly…
JA-1124 France Single Use Sartorius Stedim FMT SAS Ave de Jougues, Aubagne, Cedex July 6-9, 2020 Sterile bags, single use system…
Audit Requested US IT software LabWare TBD TBD, remote
Audit Requested US IT software Siemens TBD TBD, remote
Audit Requested US IT software Outer Edge TBD TBD, remote
Audit Requested US Packaging PRENT Janesville TBD pre form therm trays…
Audit Requested US Basid Chem/Raw Material Greenfield Global Brookfield, CT Dec 3rd, 2020 Ethanol Absolute …
Audit Requested Germany Basid Chem/Raw Material CellGenix Freiburg im Breisgau Oct 6th, 2020 Interleuken-2 (IL-2) …
Audit Requested US Excipient/Raw Material Foremost Farms ROTHSCHILD September 17, 2020 Fastflo Lactose…
Audit Requested US Basid Chem/Raw Material KNF clean room products corp Vineland September 22-23, 2020 Autoclavable bags used in QC…
Audit Requested Germany Excipient Merck Darmstadt Nov 18-19, 2020 Isopropylic Alcohol Glycerin Sodium Hydroxide…
Audit Requested Japan Excipient/Raw Material Ajinomoto Saga-Gun TBD - Q4, 2020 Amino acids, etc…
Audit Requested Japan Basid Chem/Raw Material Asahi Kasei Medical Nobeoka TBD - Oct/Nov 2020 Sterile Cartridge Planova, etc…
Audit Requested Japan Basid Chem/Raw Material Asahi Kasei Medical Oita city TBD - Oct/Nov 2020 Sterile Cartridge Planova, Filter Planova,…
Audit Requested Austria Basic Chem/Raw Material Cytiva, formerly part of GE Healthcare Life Sciences Pasching TBD Cell Culture Dry Powder Media…
Audit Requested US Excipient Archer Daniels Midland Southport TBD Citric Acid Anhydrous…
JA-1123 Mexico Single-Use Systems Corning Science Reynosa Remote audit July 21st/22nd, onsite audit Oct 14th, 2020 sterile consumables (centrifuge tubes, micro-centrifuge…
Audit Requested Japan Packaging Daikyo Seiko Sano-shi Q1 2021 rubber stopper, etc…
Audit Requested US Excipient Sensient colors St Louis TBD Yellow Iron Oxide, Siena Iron…
Audit Requested US Single Use/Basic Chemcial ELDON JAMES CORP in DENVER, United States Denver Q4 2020 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…
Audit Requested China Basic Chem/Raw Material Merck KGaA (MilliporeSigma in N.A.) Nantong Q1 2021 TBD…
Audit Requested China Basic Chem/Raw Material Merck KGaA (MilliporeSigma in N.A.) Wuxi Q1 2021 TBD…
Audit Requested United States Single-Use Systems MilliporeSigma (Merck KGaA) - formerly EMD Millipore Jaffrey, NH TBD TBD…
Audit Requested Germany API/Excipient BASF Carl-Bosch-Str. 38, Ludwigshafen TBD - Oct/Nov 2020 API's Excipients POVIDONE KOLLIDON PF 12…
Audit Requested United Kingdom single use WATSON-MARLOW LTD in FALMOUTH, United Kingdom FALMOUTH Q4 2020 Schlaeuche Schlauch Innend. 1.6x2.4mm…
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 …
Audit Requested France Basic Chemicals/Raw Materials Lasaffre Ingredients Services (Procelys/Biospringer) Cerences TBD Yeast Extract…
Audit Requested Singapore Packaging West Pharmaceutical Services, Inc. 15 Joo Koon Circle TBD (Nov 2020) TBD…
Audit # Region Standards Company Location Date Materials