Buenos Aires, November 21 (NA) – The National Administration of Drugs, Foods and Medical Technology (ANMAT) has preventively suspended the production activities of the company DRAWER S.A. after finding critical deficiencies during an inspection. The laboratory, located in the city of Quilmes and responsible since 1985 for the manufacturing and marketing of hospital medicines, was notified by ANMAT of its suspension due to the discovery of significant deficiencies classified as critical and major. According to the document obtained by the Argentine News Agency, “these shortcomings could compromise the quality, safety, and efficacy of the products manufactured at the establishment.” Following the ruling, the authorities issued a Warning Letter that implies the temporary suspension of manufacturing and marketing: “In the inspection between November 11 and 18, 2025, the acting commission of inspectors from the Department of Inspection of the Directorate of Inspection and Risk Management of the National Institute of Medicines detected and documented in the Inspection Report non-compliances with the current national regulations on Good Practices (GMP) for Manufacturers/exporters of Medicines.” It was emphasized that it was not possible to obtain information on the “integrity of data, absence of traceability of records, among others; deficiencies in production; poorly classified clean areas; inadequate monitoring; insufficient staffing; poor qualification and training of personnel; the quality control laboratory exhibits methodological and documentary deficiencies that affect analytical reliability; among others.” In this way, the company “will not be able to continue its production, quality control, and commercial activities until it complies with the deficiencies and has the corresponding Closure Letter in its possession. Likewise, the use, marketing, and distribution throughout the national territory were prohibited, and the company DRAWER S.A. was ordered to recall the following four batches from the market. The document also indicated the immobilization of 139 batches and the prohibition of use of the products preventively, which are mentioned in the Warning Letter. ANMAT indicates to institutions “not to use these batches of products until the regulatory measure is established and the investigations of the case are concluded”.
