Following an inspection conducted in July 2015, the French National Agency for Medicines and Health Products Safety (ANSM) has suspended the production of alginic acid and alginates for pharmaceutical, personal care or medical device applications, at Cargill’s Lannilis facility in France.
According to ANSM, the manufacturing process does not comply with regulations applicable to materials that are intended to be used in pharmaceutical and cosmetic products. [1] Among others, the ANSM pointed out "the lack of cleanliness of the manufacturing environment," "insufficient cleaning procedures," "the lack of adequate records of production batches," as well as the absence of the required authorization for the production of alginic acid.
“In July, 2015, ANSM undertook a scheduled inspection of our alginate plant in Lannilis, France and raised considerations regarding the manufacturing process of alginic acid and alginates for pharmaceutical and personal care or medical device applications. Cargill is disappointed with this result and is investigating its legal options as we consider this decision out of proportion. We reiterate that all of our products consistently undergo quality control before shipping. We are convinced that all products shipped from Lannilis were and are in compliance with the specifications agreed with our customers,” a spokeswoman for Cargill told Premium Beauty News.
ANSM required Cargill customers to withdraw from the market all the products containing the concerned ingredients or to perform analyses demonstrating for each product the absence of any risk to human health.
“We will continue to address the concerns of the authorities and ensure our processes comply with all necessary regulations. We regret and apologize for the inconveniences this situation generates and are committed to do our utmost to address the needs of our customers. Even if we are convinced that all products shipped from Lannilis were and are in compliance with the mutually agreed specifications - we have taken immediate actions to improve our procedures for the health products (pharmaceutical, medical devices and personal care) and also took the initiative to suspend the health production lines (pharmaceutical excipient, medical devices and personal care) and deliveries until we had more clarity on the final decision of the ANSM,” added Cargill.
