Abiomed, Inc. [Danvers / United States of America]

Abiomed, Inc. [Danvers / United States of America] located in DANVERS MASSACHUSETTS, United States of America had its last known inspection on 13 Apr 2023. There are 14 known inspections on record.

Site Details

Industries:
Medical Devices, Human Drugs
Tags:
Medical Devices, Human Drugs, Medical Device Manufacturer, Manufacturer
Last Inspection Date:
13 Apr 2023
FEI:
1220648
Redica ID:

Abiomed, Inc. [Danvers / United States of America]'s Most Recent Documents

Publish Date Document Type Title
April, 2023 FDA 483 Abiomed, Inc. - Form 483, 2023-04-13
October, 2020 EIR Abiomed, Inc. - EIR, 2020-10-06
July, 2017 EIR Abiomed, Inc. - EIR, 2017-07-27
March, 2010 FDA 483 Abiomed, Inc. - Form 483, 2010-03-17
December, 2006 FDA 483 Abiomed, Inc. - Form 483, 2006-12-18

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.

Site Profile Icon

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