The ANMAT prohibited the marketing of a series of ophthalmological products

In detail, according to the investigation of the national entity, the same they lack health records corresponding documents that account for their preparation and manufacturing conditions. The measure became effective after the publication of Provision 11068/2024 in the Official Gazette.

The ANMAT banned a series of ophthalmological products

The decision of the national administration began after the Market Control Department will carry out an inspection at the company’s address, located at Av. Fuerza Aérea 4642 in the City of Córdoba. After touring the facilities, the person responsible for the company’s activity reported that “it was dedicated to the manufacture and sale of ophthalmological instruments and stated that it was authorized by the Ministry of Health of the Province of Córdoba as a large-scale laboratory.

However, the ANMAT later detailed that “a consultation was made with the Directorate of Pharmacy Jurisdiction of the Ministry of Health of the province of Córdoba, which reported in a note dated 09/16/2024 that the firm is with the expired authorization since 09/04/2019 and that it has not registered any product with that Directorate.” In addition, it was confirmed that the company OFCOR SRL “There is no record of registration in the National Registry of Medical Technology Producers and Products (RPPTM), of this National Administration, of products with ownership exercised by the firm”.

“For the above reasons, since the products were not subjected to the evaluation of the health authority, the Directorate of Evaluation and Monitoring Management of Health Products understood that They are unaware of the features, functionality and security of the medical products in question, and it is appropriate, consequently, to consider them dangerous to health,” explained the ANMAT.

Given the lack of corresponding records for the production of ophthalmological products, the ANMAT decided to prohibit “the use, marketing and distribution throughout the national territory of all OFCOR brand products or that declare to be manufactured by OFCOR SRL, until they obtain their corresponding health authorizations.” On the other hand, the administration opened a summary health to the aforementioned company.

The ANMAT prohibited the marketing and sale of a brand of cheese

In another measure, the ANMAT prohibited the production, fractionation and marketing throughout the national territory, and on online sales platforms of the products. Argentine mozzarella cheese from the Dutch tambería brand. The investigation began from a notification from the General Directorate of Control of the Food Industry of the province of Córdoba in relation to the marketing of the product.

It arose as a result of a consumer complaint who stated that he wanted to verify the veracity of the records displayed on the label of the aforementioned article. After this, the General Directorate of Food Industry Control of the province of Córdoba intervened and confirmed that verified in its information database that the number of the National Establishment Registry (RNE) N° 040020.77 and the National Registry of Food Products (RNPA) No. 04022992 that are displayed on the label of the investigated product are non-existent.

As a consequence, the ANMAT detailed: “since it is a product that cannot be reliably and clearly identified as produced, processed and/or fractionated in a specific establishment, “It may not be produced in any part of the country, nor marketed or sold in the territory of the Republic.”

“In order to protect the health of citizens from the consumption of illegal products, whenever they are food products that lack registration, which is why their traceability, their production conditions, their quality with adequate levels cannot be guaranteed. under the conditions established by current regulations and their safety,” they added from the ANMAT.

Due to the lack of product manufacturing traceabilitythe ANMAT defined prohibiting the “preparation, fractionation and marketing of the product throughout the national territory and on online sales platforms: “ARGENTINE MOZZARELLA CHEESE brand TAMBERIA HOLANDESA, ESTABLISHMENT: RNE: 040020.77, RNPA: 04022992“, in any presentation, lot and expiration date”.

Finally, the administration also vetoed the marketing of those articles that display health records RNE 040020.77 and/or RNPA 04022992 on their labels, as they are falsely labeled products that use non-existent registration numbers.