RESOLUÇÃO-RE Nº 3.242, DE 13 DE NOVEMBRO DE 2019
| Data de publicação | 18 Novembro 2019 |
| Data | 13 Novembro 2019 |
| Páginas | 33-33 |
| Órgão | Ministério da Saúde,Agência Nacional de Vigilância Sanitária,Quinta Diretoria,Gerência-Geral de Fiscalização Sanitária |
| Seção | DO1 |
RESOLUÇÃO-RE Nº 3.242, DE 13 DE NOVEMBRO DE 2019
O Gerente-Geral de Inspeção e Fiscalização Sanitária, no uso das atribuições que lhe confere o art. 171, aliado ao art. 54, I, § 1º do Regimento Interno aprovado pela Resolução da Diretoria Colegiada - RDC n° 255, de 10 de dezembro de 2018; resolve:
Art. 1º Adotar a(s) medida(s) preventiva(s) constante(s) no ANEXO.
Art. 2º Esta Resolução entra em vigor na data de sua publicação.
RONALDO LUCIO PONCIANO GOMES
ANEXO
1. Empresa: NCPC Hebei Huamin Pharmaceutical Co., Ltd - Cadastro único: B.0137
Produto - Apresentação (Lote): CEFUROXIMA SÓDICA (); CEFOTAXIMA SÓDICA ();
Tipo de Produto: Insumo Farmacêutico
Expediente nº: 3120957/19-2
Assunto: 70351 - MEDIDA PREVENTIVA- Ações de Fiscalização em Vigilância Sanitária
Ações de fiscalização: Suspensão - Comercialização, Distribuição, Importação, Uso
Motivação: Considerando a suspensão pelo European Directorate for the Quality of Medicines & HealthCare - EDQM do certificado de adequabilidade dos insumos Cefotaxima Sódica e Cefuroxima Sódica devido a não conformidades críticas e maiores detecyadas...
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