Injunction of the ANSM to the company Unilever HPC
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It is because of “non-compliances and significant deficiencies” that the ANSM has just sent to Unilever HPC company a compliance injunction concerning its Le Meux facility. The cause: several deviations relating to compliance with the requirements of ISO 22716 on Good Manufacturing Practices.
This injunction, dated December 20, 2019, follows an inspection of the ANSM carried out at the premises of this company from April 23 to 25, 2019.
The alleged facts
• Risk of contamination of the products with regard to the organization of the premises and the lack of control of the production environment.
• Lack of control over the control and release of raw materials and packaging items upon receipt.
ANSM enjoins Unilever HPC to:
• Implement the work necessary to ensure the definition, separation and maintenance of the zones as well as the maintenance of the equipment, within 9 months
• Implement controls on receipt of packaging items, within 3 months
• Set up appropriate controls on receipt for all raw materials according to defined methods in order to release the raw materials with regard to the defined acceptance criteria, within 3 months