Brazilian health authorities have shut down a compounding pharmacy and launched an investigation into a distributor following the discovery of significant sanitary issues that could compromise patient safety. The actions, carried out by the National Health Surveillance Agency (Anvisa) in partnership with state and local health authorities, highlight ongoing concerns about quality control in the production of sterile medications.
The Terapêutica Farmácia de Manipulação LTDA, located in São José dos Campos, had its production of sterile drugs immediately halted on March 19, 2026, and is prohibited from selling these products until deficiencies are addressed. Inspections began on Monday, March 16, and too included the Mali Produtos para Saúde LTDA distributor, where similar problems were identified.
Pharmacy Issues
Inspectors found critical deficiencies in the pharmacy’s cleaning procedures for equipment and utensils used in drug preparation, raising concerns about potential contamination. The pharmacy lacked validated processes for sterilizing products – a crucial step for medications intended to be free of microorganisms like bacteria, viruses, and fungi. This is particularly concerning given the pharmacy was compounding a combination of tirzepatide, vitamin B12, and glycine, a mixture for which efficacy and safety have not been evaluated.
The investigation also revealed the pharmacy was producing formulations of anti-obesity pens, commonly known as “weight loss pens,” with concentrations matching those of commercially available, industrially produced drugs. Compounding pharmacies are intended to meet the specific needs of patients through personalized prescriptions when commercially available options are insufficient, and producing duplicates of existing medications is prohibited.
Further issues included problems with the air handling system and the physical infrastructure of the facility. Records of controlled medications and ingredients, such as hormones, were incomplete. Refrigerated medications and ingredients were stored in standard refrigerators without proper temperature monitoring. An unapproved construction project was also underway at the facility, potentially introducing risks of contamination to the production environment.
The actions are part of Anvisa’s program specifically focused on the oversight of sterile medications.
Distributor Findings
Similar record-keeping issues were found at the Mali Produtos para Saúde LTDA distributor. Problems were also identified in the storage of ingredients used to produce the anti-obesity pens, with materials stored in standard refrigerators without proper qualification or segregation. The distributor also lacked adequate quality assurance systems and a validated method for ensuring medications were transported under ideal conditions.
The inspections of both companies were completed on Wednesday, March 18, 2026.
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