Spanish inspectors cracked down on Barcelona-based generic drug manufacturer Novocat Farma after a June inspection found that its staff had failed to keep track of quality problems for almost six months.
Based on what inspectors found on-site, the regulators pulled its current GMP certificate and temporarily suspended its authorization to manufacture drugs.
In a posting on the EudraGMDP website, the Agencia Espanola de Medicamentos y Productos Sanitarios detailed results of that June visit. Inspectors found that the site's technical director wasn't replaced while she was on sick leave, and they concluded that staffers had forged her signature while she was out.
The company's records included “documents presumably signed by her (the technical director on leave) in which the signature is falsified," the report stated.
Inspectors also found that Novocat’s quality assurance system had stopped working “on a regular basis” beginning in January. Deviations and out-of-specification results weren't recorded.
“The procedures that are followed in the quality control laboratory are not adequate to ensure compliance with GMP in the analysis of medicinal products,” the report said.
Novocat develops and licenses drugs, primarily generics, the company's website says. It makes eye and skin drugs, injectable medications, oral powders and other products at its site in the Barcelona area.