Inspection Record

Linde Gaz Romania S.R.L. — EU GMP NCR (EudraGMDP) Findings

EMA (Europe)Inspected 2022-03-31Published 2023-03-22 1 findingsLaboratory and QC controls

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Findings

1Laboratory and QC controls

Release/distribution for administration to patients of human medicinal product Linde Oxygen 100% (v/v), compressed medical gas for which the Declaration of Conformity was submitted without the signature of the qualified person and for which it was not possible to provide the quality control by the person in charge of quality control or his substitute (both persons were not available on site for testing) Action taken/proposed by the NCA: Suspension of the manufacturing authorisation No. 28F in Part Withdrawal, of current valid GMP certificate No. 016/2019/RO Withdrawal of current valid GMP certificate no.016/2019/RO

About this record

Extracted automatically from the document EMA (Europe) published on 2023-03-22. 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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Linde Gaz Romania S.R.L. company profile — full history EMA (Europe) documents, 2023 Go to Findings search