It is in the name of"nonconformities and important failures" that the ANSM has just sent to the Lorcos company an injunction to bring its Lunéville establishment into conformity. In question: several discrepancies relating to compliance with the requirements of ISO standard 22716 on Good Manufacturing Practices.
This injunction, dated July 2, 2018, follows an inspection by the ANSM carried out on the premises of this company from November 20 to 22, 2017.
The facts complained of
- Certain raw materials are released from the analysis report without control upon receipt, which is insufficient with regard to chapters 6.2, 6.5, 9.3 and 17 of the harmonised standard NF EN ISO 22716 of January 2008 on Good Manufacturing Practices for cosmetic products.
- Water quality is not sufficiently controlled in view of the control method, the results presented and the available documentation, in accordance with chapter 6.8 of the harmonised standard NF EN ISO 22716 of January 2008 on Good Manufacturing Practices for cosmetic products.
- The absence of proof to ensure the validity of the microbiological method used for the control and 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.
- Production areas are not separated, in particular the areas for the sampling and weighing of raw materials and the manufacture of liquid products, in accordance …
