Thursday, March 9, 2017ANSM

Injunction of the ANSM to Cosinus & Servicosm

© CosmeticOBS-L'Observatoire des Cosmétiques

The ANSM has just sent Cosinus and Servicosm (cosmetic subcontracting companies) an injunction to bring their Dreux establishments into compliance in the name of"non-compliance and major shortcomings". In cause: several discrepancies relating to compliance with Good Manufacturing Practices.

Reading time
~ 3 minutes

This injunction, dated 3 March 2017, follows an ANSM inspection carried out on the premises of these companies on 13, 14 and 15 September 2016.

The facts complained of

a) The quality of the water used in production is not sufficiently controlled in accordance with chapter 6.8 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products. (b) The absence of a cleaning and disinfection programme for all production equipment in accordance with Chapters 4.10 and 5.5 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practice for cosmetic products. c) Storage conditions for products that do not meet the requirements of chapters 6.6 and 7.2.6 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products. d) The absence of appropriate controls of raw materials, release of raw materials and management of raw material expiry dates in accordance with chapters 6.1, 6.3, 6.4, 6.5, 6.6 and 6.7 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products. e) The absence of management of bulk products and control upon receipt at Servicosm in accordance with chapters 7.1, 7.2.4, 7.2.5 and 7.2.6 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products. f) Traceability of production operations which is not established to ensure compliance with chapters 7.1, 7.2, 7.3.2, 7.3.3, 17.1 and 17.2 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products. g) The absence of quality documentation for Servicosm in accordance with chapter 17 of the harmonised standard NF EN ISO 22716 of January 2008 relating to good manufacturing practices for cosmetic products. h) The absence of separation of the laundry in the storage and cleaning area from all areas where good manufacturing practices must apply in accordance with chapters 4.1, 4.2, 4.6, 4.9 and 6.6 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products. i) The absence of subcontracts established with all principals in accordance with Chapter 12 of the harmonised standard NF EN ISO 22716 of January 2008 on good manufacturing practices for cosmetic products.

The injunction

a) Ensure that the water used in production is of defined and controlled quality, within 3 months. (b) Establish cleaning and disinfection programmes for all equipment within 3 months. c) Set up a defined and appropriate storage of products, within 3 months. d) Set up an appropriate control of raw materials on receipt under suitable and defined conditions and manage their expiry, within a period of 3 months. e) Carry out checks on all bulk products before packaging, within 3 months. (f) Ensure traceability of production operations within 3 months. g) Set up quality documentation for Servicosm within 3 months. (h) review the definition and separation of the areas and their cleaning, in particular for the levery and for the areas intended for manufacture, within six months. i) Have contracts with the principals within 6 months.

CosmeticOBS - Observatoire des Cosmétiques
© 2017- 2020  CosmeticOBS

ANSMOther articles

97results