Spanish officials yank Novocat's GMP certification after inspectors turn up serious shortfalls

Barcelona Spain
Barcelona-based generic drug manufacturer Novocat Farma was cited by Spanish regulators for a number of manufacturing noncompliance issues following an inspection earlier this summer. (Getty Images)

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.

Featured Webinar

How to Streamline Your Clinical Research Organization's Processes End to End

Learn how implementing one platform leads to data consistency and ultimately facilitate faster clinical trials while reducing overall trial costs, leave behind spreadsheets and home-grown tools for a predictable trial and the ability to forecast unit delivery resulting in the optics you need to ensure a successful trial, and hear experts share industry trends of what is affecting the Clinical Research Organization industry today.

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.

Suggested Articles

Three facts about how distributors are managing in-demand inventory.

Novartis’ latest campaign with a celebrity dance partner asks people to bust a move to raise awareness around sickle cell anemia and therapy Adakveo.

Purdue has reached an $8 billion settlement with the U.S. government to settle criminal and civil charges for its role in the U.S. opioid crisis.