This ANSM decision is dated 12 April 2016. It orders the suspension of the manufacture, export, distribution and placing on the market of cosmetic products manufactured at CTRC JF Lazartigue's Trappes site.
CTRC JF Lazartigue is a manufacturing and packaging establishment for products falling within the definition of cosmetic products within the meaning of Article 2 of European Regulation 1223/2009. The text of this animal health decision recalls that, as such, the manufacture of products must comply with GMP (Good Manufacturing Practices) in order to guarantee a high level of protection of human health. Compliance with these GMPs is presumed when manufacture is carried out according to ISO 22716.
On November 25 and 26, 2015, an inspection of the company's premises located at Trappes was conducted by the ANSM, and the manufacturing conditions of cosmetic products were deemed not to comply with this standard for several reasons (lack of protection of manufacturing areas, inadequate cleaning, failure to control the quality of water used in production, etc.).
Considering that the responses provided by CTRC JF Lazartigue are insufficient and that the products manufactured at the Trappes site are likely to harm human health, the ANSM has therefore decided to suspend the manufacture, export, distribution and marketing, free of charge or against payment, of cosmetic products manufactured at the Trappes site of CTRC JF Lazartigue until they comply with the legislative and regulatory provisions applicable to them.
