Inspection Record

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

EMA (Europe)Inspected 2022-04-05Published 2023-03-22 1 findingOther 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

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.

Translation and classification are automated and may differ in nuance from the source.

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