FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Brazilian Manufacturer Called Out for Slew of Violations

Sept. 25, 2018

The FDA cited Brazilian OTC drugmaker Pietrobon for multiple violations including testing and equipment problems and poor recordkeeping.

A May 7-10 inspection of the firm’s facility in Rio Grande do Sul revealed that it failed to perform stability studies for one OTC drug product, which means it could not assure the product’s safety, efficacy or shelf life.

The firm also neglected to conduct final specification, identity and assay testing of its finished OTC drugs.

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