# BioSphere Medical S.A. – FDA Inspection, Jun 16, 2016

Source: https://www.keypedia.com/records/fda_inspections/biosphere-medical-sa/8e5884da-1b39-452b-ab1a-6311bf120494
Source feed: FDA_Inspections

> FDA inspection 978525 of BioSphere Medical S.A., June 16, 2016. Classification: Voluntary Action Indicated (VAI). 8 citations under 21 CFR parts 803 and 820. 3 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 978525
- Company Name: BioSphere Medical S.A.
- Inspection Date: 2016-06-16
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Compliance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 8

## Related Documents

- [FDA Inspection 1134765 - 2018-08-03](https://www.keypedia.com/records/fda_inspections/biosphere-medical-sa/60b3f498-104a-462a-89b4-8baa75d3f9e7)
- [FDA Inspection 756570 - 2011-12-01](https://www.keypedia.com/records/fda_inspections/biosphere-medical-sa/9ebf7555-8a87-4326-8ba6-9387557dc3ed)
- FDA Inspection 592355 - 2009-06-19

Company: https://www.keypedia.com/companies/biosphere-medical-sa/40a5f60c-6a3b-4223-8297-5b15b0fc462f

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
