Octapharma AB [Stockholm / Sweden]
Octapharma AB [Stockholm / Sweden] located in STOCKHOLM STOCKHOLMS LÄN, Sweden had its last known inspection on 19 Sep 2023. There are 18 known inspections on record.
Site Details
Industries:
Human Drugs,
Biologics
Tags:
Biologics,
Manufacturer,
Analytical Testing,
Label,
Packaging,
FDF Manufacturer,
Biologics API Manufacturer,
Biologics Manufacturer
Last Inspection Date:
19 Sep 2023
FEI:
3005559915
Redica ID:
Investigators:
Pankaj H Amin,
Michael C Kennedy, PhD,
Andrey Sarafanov, PhD,
Rebecca K Olin,
Alan L Truong,
LCDR Debra Emerson,
Cynthia Jim, CSO,
Susan M Jackson,
Randa Melhem, PhD,
Eileen A Liu,
Olga Simakova, PhD,
Nancy Kirschbaum, PhD,
Jennifer L Reed,
Michael J Vardon,
Jacqueline Mdiaz Albertini,
Scott T Ballard,
Ze Peng,
Mihaly S Ligmond,
Jie He,
Prabhu P Raju,
Joan A Loreng,
Anthony F Lorenzo,
Mikhail V Ovanesov, PhD
Octapharma AB [Stockholm / Sweden]'s Most Recent Documents
Publish Date | Document Type | Title |
---|---|---|
October, 2016 | FDA 483 | Octapharma AB - Form 483, 2016-10-03 |
July, 2016 | FDA 483 | Octapharma AB - Form 483, 2016-07-14 |
July, 2012 | FDA 483 | Octapharma AB - Form 483, 2012-07-30 |
January, 2012 | FDA 483 | Octapharma AB - Form 483, 2012-01-19 |
January, 2011 | FDA 483 | Octapharma AB - Form 483, 2011-01-20 |
Experience Redica Systems’ NEW site dashboards and profiles
Redica Systems customers can leverage the full Quality and Regulatory Intelligence suite, with powerful analysis covering thousands of sites around the world. You can search by FEI, or more powerfully, by the Redica ID, our universal identifier for global life sciences manufacturing sites, an industry first.
Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.
Loading...
Site Profiles Are Just the Tip of the Iceberg
Becoming a Redica Systems customer not only provides you with unlimited access to our extensive inventory of site profiles, but also grants you access to:
Inspection Intelligence
- Pre-Approval Inspection (PAI) trends
- The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
- Latest 483s: see what the trends are across all FDA Investigators
- CFR Heatmap: Citations aggregated by Subpart by Year
Vendor Intelligence
- Full inspection histories for your vendors down to the specific site level
- All of the functionality mentioned above but isolated to just your vendors
Regulatory Intelligence
- Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
- All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more