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Tuesday, October 24, 2017Authorities

Injunction of the ANSM to the S.F.F.C.

© CosmeticOBS-L'Observatoire des Cosmétiques

It is in the name of"non-conformities and important failures" that the ANSM has just sent to the Société Française de Fabrication de Cosmétiques (S.F.F.C.) an injunction to bring its Mourenx establishment into conformity. The cause: several discrepancies relating to compliance with the requirements of the ISO standard on Good Manufacturing Practices.

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This injunction, dated 17 October 2017, follows an inspection by the ANSM carried out on the company's premises from 15 to 17 February 2017.

The facts complained of

- The absence of separation, identification and/or protection of the weighing area where good manufacturing practices must apply in accordance with Chapter 4 of the harmonised standard NF EN ISO 22716 of January 2008. - The lack of definition of adapted cleaning programmes for all production equipment in accordance with chapter 5.5 of the harmonised standard NF EN ISO 22716 of January 2008. - The absence of audits of subcontractors in charge of manufacturing and/or packaging in accordance with chapter 12 of the harmonised standard NF EN ISO 22716 of January 2008.

The injunction

The ANSM enjoins the Société Française de Fabrication de Cosmétiques (S.F.F.C.) :  1. to set up a separation in order to ensure the protection of the weighing room within 6 months;  2. finalize the demonstration of the effectiveness of cleaning programs for all equipment within 3 months;  3. to undertake an audit of subcontractors to ensure that subcontracted operations are under control within 6 months.

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