The National Authority for the Safety of Medicines (ANSM) announced on Monday to suspend the authorization of the activities of the company Givaudan-Lavirotte related to the manufacture of pharmaceutical products due to deficiencies observed during various inspections.
The drug sector policeman explains that the corrective measures he had requested after an inspection in 2021 “were not considered sufficient” after a new inspection carried out in October 2022.
Exemptions to avoid ruptures
The ANSM points out “particularly serious non-compliance with good manufacturing practices, particularly in terms of cleaning and maintenance of premises and equipment”, as well as deficiencies in quality management and “control of active substances used in the manufacture of medicines”.
“These provisions will be maintained until compliance with the regulations regarding raw materials for pharmaceutical use,” underlines the press release.
To avoid any risk of rupture, the ANSM indicates that the manufacturers of medicines whose raw materials come from the Givaudan-Lavirotte company can “request, exceptionally and temporarily, an exception to the decision.”
Located in Lyon, Givaudan-Lavirotte manufactures active ingredients and excipients for pharmaceutical use, as well as mineral salts used in the manufacture of nutritional and cosmetic products.
Source: BFM TV
