Argentina's ANMAT bans medical products from Lead Cables after unapproved factory found

Argentina's National Administration of Drugs, Food and Medical Devices (ANMAT) issued a prohibition on the use, sale and distribution of medical products manufactured by Lead Cables y Accesorios S.R.L. The ban covers the entire country and follows the discovery that the company was operating in a facility not authorized by health authorities in Hudson, Berazategui, Buenos Aires Province. ANMAT also suspended the firm's Good Manufacturing Practices certificate (No. 523‑2022‑R) and opened a sanitary investigation against the company and its technical director. Inspectors noted that the firm had been warned to obtain proper licensing, failed to comply within the 30‑day deadline, and appeared to relocate production to an unverified site in La Plata. The agency concluded that without a verified sanitary inspection it could not guarantee product safety, prompting the preventive ban until the company regularizes its status.

The decision was formalized in Disposition 4158/2026 and published in the official bulletin, reflecting ANMAT's enforcement of strict regulatory standards for medical device manufacturing in Argentina.