Inspection Record

Biogalenica Project & Consulting S.R.L. — EU GMP NCR (EudraGMDP) Findings

EMA (Europe)Inspected 2022-04-05Published 2023-03-22 1 findingsOther quality system

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Findings

1Other quality system

Marketing of a product, potassium iodide capsules of 65 mg equivalent to 50 mg iodine, which does not have a Marketing Authorization issued by NAMMDR. Action taken/proposed by the NCA: Suspension of the manufacturing authorisation No. 56F in Full Withdrawal, of current valid GMP certificate No. 009/2018/RO withdrawal of current valid GMP Certificate no.009/2018/RO

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Extracted automatically from the document EMA (Europe) published on 2023-03-22. The source is available at the link above.

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Biogalenica Project & Consulting S.R.L. company profile — full history EMA (Europe) documents, 2023 Go to Findings search