It is in the name of"non-compliance and significant breaches" that the ANSM has just sent Intuiskin a compliance injunction concerning its establishment in the 8th arrondissement of Paris. The cause: several product safety and GMP compliance discrepancies.
Following the regularisation of the situation, this injunction was lifted on 31 August 2017.
This injunction, dated February 7, 2017, follows an ANSM inspection carried out on the company's premises on August 31 and September 1, 2016.
The facts complained of
(a) The failure to compile safety reports on customised Ioma brand products in accordance with the requirements of Regulation 1223/2009. b) The failure to update the safety assessment established in accordance with Directive 76/768/EEC for the product Sublime Cream - Ioma placed on the market, in accordance with Annex I Part B and Article 11 of Regulation 1223/2009 on cosmetic products. c) Manufacturing and packaging activities of cosmetic products at the point of sale including rules of hygiene, manufacturing, control, release of finished products and documentation are not established in accordance with Article 8 of Regulation 1223/2008 and according to the requirements of ISO standard 22716 on good manufacturing practices for cosmetic products. d) Insufficient control of subcontracting 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
1) To have formulas, safety reports and information dossiers to frame all combinations of finished products resulting from the mixture of a cream base (day or night) with sera in order to guarantee that the finished products used by consumers are evaluated on the basis of the appropriate information and that they are safe for human health as provided for in Regulation 1223/2009, within a period of 6 months. 2) Have the safety assessment for the product Sublime Cream - Ioma placed on the market in compliance with the requirements of Regulation No. 1223/2008, within 6 months. 3) To comply with good manufacturing practices at store level, including controls and the release of custom products prepared in stores to guarantee their quality, within 6 months. 3) Have contracts with subcontractors and initiate an audit process to ensure that subcontracted operations are under control within 6 months.
To go further
- See the
Injunction No 16COS082-INJ concerning the establishment of the company"Intuiskin", located in Paris (8th),
on the ANSM website.
