Inspection Record

Anthroposan Homoeopharm Produktionsgesellschaft mbH — EU GMP NCR (EudraGMDP) Findings

EMA (Europe)Inspected 2020-12-09Published 2021-11-12 1 findingsOther quality system

View the regulator's official source The source document is always the basis for judgement.

Findings

1Other quality system

The result of the November 17 and December 9, 2020 inspection of the company revealed two critical and twelve major non-compliances. There is no sufficiently documented and controlled pharmaceutical quality management system. In addition, Section 38 (1) of the German Medicines Act was violated. Requests for statements on the deficiencies and hearings on the planned revocation remained unanswered. Action taken/proposed by the NCA: Revocation of the manufacturing authorisation No. DE_TH_01H_MIA_2019_0018 in Full

About this record

Extracted automatically from the document EMA (Europe) published on 2021-11-12. 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.

Anthroposan Homoeopharm Produktionsgesellschaft mbH company profile — full history EMA (Europe) documents, 2021 Go to Findings search