This injunction, dated 14 March 2017, follows an inspection by the ANSM carried out on the company's premises from 4 to 6 October 2016.

The facts complained of

- The absence of mandates to designate and identify the person responsible for certain products in accordance with Article 4 of Cosmetic Regulation 1223/2009. - The quality of the water used which is not controlled in accordance with chapter 6.8 of the harmonised standard NF EN ISO 22716 of January 2008 relating to good manufacturing practices for cosmetic products. - The control of raw materials and finished products which are insufficient with regard to chapters 6.5, 6.7 ; 8 and 9.3 of the harmonised standard NF EN ISO 22716 of January 2008 relating to good manufacturing practices for cosmetic products. - The release of finished products which is not carried out on the basis of a complete batch dossier, in accordance with chapter 8.2 of the harmonised standard NF EN ISO 22716 of January 2008 relating to good manufacturing practices for cosmetic products. - Insufficient evidence to ensure the validity of the microbiological method used for the release of finished products with regard to the methods defined in the standards in force, in accordance with chapters 8 and 9 of harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products and Article 12 of Regulation 12238/2009. - The absence of investigation, documentation and approval by authorized personnel for results and products outside specification, in accordance with chapters 9.5 and 10 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products. - The absence of safety reports and information files (DIP) for certain products placed on the market by Phytomedica in accordance with Articles 4, 10 and 11 of Regulation 12238/2009. - The marketing of cosmetic products indicating that they may be mixed with any other cosmetic product by consumers, which is not a practice regulated by the Regulation, especially since the company has not demonstrated the safety of products obtained after mixing, in accordance with Recitals 4 and Articles 3, 4 and 10 of Regulation 12238/2009. - The absence of contracts with subcontractors and principals in order to establish responsibilities, in accordance with Chapter 12 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products. - Non-operational document management that does not properly document the site's GMP activities, in accordance with chapter 17 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products.

The injunction

ANSM enjoins Phytomedica Laboratories :

Within 3 months  1. to have written and signed mandates between the different manufacturers and the responsible person they designate, in accordance with the requirements of Regulation 1223/2009, in order to meet the regulatory obligations applicable to the responsible person in particular in terms of labelling;  2. review the control and monitoring of the water treatment system used in production to ensure water quality;  3. to carry out appropriate controls for raw materials and finished products and to release them on the basis of appropriate documentation by a person responsible for quality;  4. to provide proof of the validity of the microbiological method used for the release of the products;  5. document surveys and decisions on results and non-specification products;

Within 6 months  6. to have the safety reports and information files for all the products marketed by Laboratoires Phytomedica, drawn up in accordance with the requirements of the Regulation;  7. review the presentation and claims on products that may be mixed with any other product and ensure that these cosmetic products are in compliance with the regulations in force ;  8. to have contracts with principals and subcontractors and to initiate an audit process to ensure that subcontracted operations are under control;  9. to set up a document management system to define site requirements and to carry out and record operations related to good manufacturing practices.

To go further
- See the Injunction No. 16COS092-INJ concerning the establishment of the company"Laboratoires Phytomedica", located in Aix-en-Provence (Bouches-du-Rhône), on the ANSM website.