Sartorius Stedim BioOutsource Contract Testing Facility in Glasgow Passes FDA Inspection

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-04-06-2016, Volume 11, Issue 4

The inspection confirmed that the facility was compliant with GMP guidelines.

Sartorius Stedim BioOutsource, a subsidiary of Sartorius Stedim Biotech, announced on March 2, 2016 that its Glasgow facility passed FDA inspection.

According to the company, the FDA compliance safety office spent two days at the facility, reviewing its quality systems and their application to the analytical services that support the testing of biologics, vaccines, and biosimilars. The inspection confirmed that the site is compliant with GMP guidelines and no Form 483 was issued.

Sartorius Stedim Biotech purchased BioOutsource in 2015, and a full-year financial results report stated the company had a positive impact on Sartorius’ 16% increase in group sales revenue. The company noted that the acquisition of BioOutsource and Cellca GmbH had an impact on sales, “contributing nearly two percentage points in constant currencies to the divisions sales expansion.”


Source: Sartorius Stedim Biotech