Bio-Thera Solutions Ltd. — Statement of GMP Non-Compliance

A statement of GMP non-compliance is the EU equivalent of an FDA Warning Letter: an EEA competent authority has found that a site does not comply with EU GMP. It can trigger recall, suspension of the manufacturing authorisation, or removal from the supply chain across the EEA.

The complete statement — the site, the inspecting authority, and the cited deficiencies — is published in the EudraGMDP database. SPEQ surfaces and indexes it for reference; the authoritative record lives on EudraGMDP.