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30.11.2018 14:58 Age: 1 year
Category: Allgemein, Pharmaanalytik, Startseite

Successful U.S. FDA Inspection of GBA Pharma Site Gräfelfing

We are pleased to announce that the GBA Pharma site in Gräfelfing was successfully inspected by the U.S. FDA (United States Food and Drug Administration) from June 25 to 27, 2018.  The 3-day inspection was carried out as a pre-approval inspection (PAI) and as an overall system audit of the processes the company has established to comply with cGMP requirements.

Besides an in-depth control of our analytical laboratories, the inspection was focused on the processes established for deviation management, CAPA (corrective and preventive action), and management of OOS/OOT/OOE (out of specification/trend/expectation) results, as well as data integrity.

The inspection was classified by the FDA as „NAI“ (no action indicated).

GBA Pharma management and staff are proud of this outstanding result which is an acknowledgement of the high quality standards in the established processes and business operations of this location.

Based upon this excellent appraisal by the U.S. FDA, GBA Pharma GmbH with its locations in Gräfelfing, Martinsried and Ulm is well prepared to support its clients with a wide range of services and to provide comprehensive consultancy – and thus to offer fast, flexible, innovative and customer-oriented solutions in the analytical and regulatory fields.