The National Administration of Drugs, Food and Medical Technology (ANMAT) banned the production and marketing of a olive oil considering it an “illegal product” because “lack health records and be falsely labeled by recording non-existent RNPA and RNE numbers on the labeling.”
According to the agency through Provision 8427/2024 published this Wednesday in the Official Gazette, it is the “Extra virgin olive oil; Don Francesco brand; Net content 2 Lts.; Best before June 27; Origin: Mendoza; Rne: 13632154; Rnpa: 13632649″. In addition, medical products were also banned made by the Torboli Gustavo Gabriel firm.
ANMAT banned the sale of olive oil
The investigations began in Mendoza after a private consumer made a query to the National Food Institute (INAL). The person in question had purchased the item in the town of Gualeguaychú.
After an exhaustive analysis, the intervening authority established that “The product is in violation of Article 3 of Law No. 18284, Article 3 of Annex II of Decree No. 2126/71, Articles 6 bis, 13 and 155 of the Argentine Food Code (CAA)for lacking health records and for being falsely labeled by including non-existent RNPA and RNE numbers on the label, resulting in it being an illegal product.”
In this way, the national administration prohibited the production, fractionation and commercialization throughout the national territory – and also on online platforms – of the product “Extra virgin olive oil; Don Francesco brand; Origin: Mendoza; Rne: 13632154; Rnpa: 13632649″. The ban is effective for any presentation, batch and date of the aforementioned article.
The decision was made because the product is in Violation for not having the required health recordsin addition to being falsely labeled by assigning non-existent RNPA and RNE numbers.
Medical products banned by ANMAT
Through Provision 8608/2024, the administration prohibited the “use, marketing and distribution throughout the national territory” of all the medical products manufactured by the Torboli Gustavo Gabriel firm. It will remain in force until the producer obtains the corresponding “Good Manufacturing Practices Certificate” again.
The affected company had initiated the process to renew the aforementioned certificate last July 13, 2021which caused the extension of its validity as permitted by ANMAT Provision 4930/17.
Subsequently, the Directorate of Evaluation and Monitoring Management of Health Products carried out inspections at the firm Torboli Gustavo Gabriel and found that it was marketing products that “They do not have the corresponding records from the National Institute of Medical Products“The administration therefore requested a ban on the products found.
Besides, ANMAT generated a health summary to the firm due to the lack of the required documentation. On June 14, 2024, inspectors from the National Administration went to the firm’s address to carry out a Good Manufacturing Practices Compliance Verification Inspection.
In its justifications, the administration detailed that, during the various procedures, it was possible to verify the “lack of corresponding health records” and explained that, in the absence of the named certificates, it cannot be guaranteed the origin, safety and efficacy of the medical products marketed by the brand.
Source: Ambito
