DIP defects, lack of product safety assessment, inorganisation of cosmetovigilance, breaches of GMP… as many reasons which motivated the injunction to bring its cosmetic activity into conformity addressed by the ANSM to the company CTRC JF Lazartigue. Within 2 to 6 months.
This is following an inspection by the ANSM (Agence nationale de sécurité des médicaments et produits de santé) carried out on the company's premises; CTRC JF Lazartigue in Trappes in December 2014, that a series of nonconformities and deficiencies qualified as important were noted:
lack of safety assessment for all products placed on the market,
- lack of compilation of product information dossiers,
- lack of consistency between the list of ingredients- failure to manage cosmetovigilance,
- failure to comply with the guidelines of ISO 22716 concerning Good Manufacturing Practices (GMP): absence of separation, identification and/or protection and cleaning of the areas concerned, absence of a programme for cleaning and disinfection of production equipment, absence of identification, management of the status, release of raw materials, etc;The lack of re-evaluation of raw materials and bulk products, poor control of water used in production, traceability of production operations, batch records, allocation of batch numbers..;
Consequently, the ANSM has just ordered the company CTRC JF Lazartigue to comply with these various points, attaching its injunction with short deadlines:
safety assessment and DIP: 6 months,
- adjustment of the consistency of formulas between DIP and labelling and implementation of cosmetovigilance: 2 months,
- GMP: 3 months.
To go further
See Injunction n° 15COS069-INJ concerning the establishment of CTRC JF Lazartigue located ZI Trappes Les Bruyères, to download below.
