France’s National Agency for Medicines and Health Products Safety (ANSM) has uncovered deficiencies at Cargill’s manufacturing site in Lannilis, France that have resulted in a major recall.
The release of the July inspection report on 30 October detailing Cargill's violations follows a s previous decision issued by ANSM on 25 September to suspend the manufacturing, packaging, licensing, distribution, exportation and the use of active ingredients and excipients manufactured by Cargill France at the site.
On the pharmaceutical side, the site manufactures the active ingredient alginic acid, which had been used by Pierre Fabre Medicament (PFM) for the manufacture of Topaal, which can treat gastro-esophageal reflux.
PFM halted the commercialization of Topaal on 27 August, and because the drug’s active substance was not manufactured in an authorized site and because the site was not compliant with good manufacturing practices (GMPs), PFM, in agreement with ANSM, decided to recall the remaining batches on the market, effective 5 October.
The site also produced alginates, which can be used as texturizing agents in applications as varied as ice creams, dental imprints or welding rods. ANSM notes that in addition to PFM, all Cargill's pharmaceutical, cosmetic and device customers have been notified of the issues pertaining to the ingredients.
Cargill spokesman Louis de Schorlemer told Focus that the company “takes the considerations of ANSM very seriously and is committed to carefully review each of the points raised and already started to implement an improvement plan.”
“However, there is no evidence for any risk for public health,” he added, noting that since Cargill began operating the site in 2006, “only one pharmacovigilance case has been reported (skin rash, October 2014), while dozens of millions of health products have been developed with our ingredients.”
Inspection Report
Overall, ANSM made 14 observations, including one critical deficiency and four major deficiencies. The critical deficiency was that the management of semi-finished batches and of the mixing operations “was deficient and conformity of the final batches to specifications, notably Ph.Eur. specifications, could not be guaranteed.”
ANSM specifies that it found non-compliant manufacturing operations around Cargill’s extraction of substance from a plant source, which in this case is for alginates extracted from brown seaweed fished from the Iroise Sea.
In addition, the site was cited for manufacturing an active substance without ANSM authorization.
“The manufacturing of the active substance had not been made using master production instructions and no batch production records had been established,” ANSM said in another major deficiency, noting that Cargill also failed to review batch production records of critical process steps before releasing the active substance for distribution.
Seven other observations from ANSM related to “lack of traceability, risks of contamination induced by the absence of cleanliness in the production environment, very bad condition of the production equipment and insufficient equipment cleaning procedures.”
ANSM calls on the concerned marketing holders to perform a review of Cargill’s quality risk management.
Inspection Report