Inspection Record

Mycoplasma Biosafety Services GmbH - Bio Tech Center Muthgasse — EU GMP NCR (EudraGMDP) Findings

EMA (Europe)Inspected 2018-05-03Published 2019-01-28 1 findingsDeviation, CAPA, and investigation

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Findings

1Deviation, CAPA, and investigation

After evaluation of the company's CAPA plan, major deficiencies in the fields of personnel and maintenance/calibration remain unsolved. Action taken/proposed by the NCA: Revocation of the manufacturing authorisation No. 482440 in Full Withdrawal, of current valid GMP certificate No. 482440-0002 Complete withdrawal of GMP certificate (INS-482440-0002-011)

About this record

Extracted automatically from the document EMA (Europe) published on 2019-01-28. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

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Mycoplasma Biosafety Services GmbH - Bio Tech Center Muthgasse company profile — full history EMA (Europe) documents, 2019 Go to Findings search