Spanish Regulator Suspends GMP Certification and Manufacturing Activities at OCB Pharmaceutical

Spanish regulatory authorities have identified serious Good Manufacturing Practice (GMP) violations at OCB Pharmaceutical S.R.L.’s manufacturing facility in Canovelles, Spain. The findings followed an inspection that concluded on 27 August 2026 and resulted in restrictions on the facility’s manufacturing and distribution activities.

According to the published regulatory report, inspectors identified nine deficiencies, including one critical and eight major observations. The most serious concern involved the repackaging and relabelling of bismuth subsalicylate obtained from a manufacturer in China operating outside the European Union’s GMP framework.

The inspection found that OCB Pharmaceutical had assigned new batch numbers to the material, reproduced supplier analytical results in certificates of analysis, and replaced or removed original labels. These practices compromised the ability to establish the material’s original manufacturer, batch identity and supply-chain history.

Additional deficiencies were reported in investigations, corrective and preventive actions (CAPA), risk management, data integrity, personnel qualification, cleaning procedures, contamination controls, facility management and quality oversight. Concerns involving environmental monitoring and heating, ventilation and air-conditioning controls also raised questions about the effectiveness of contamination-prevention measures.

Following the findings, the Spanish competent authority temporarily suspended manufacturing activities involving active pharmaceutical ingredients (APIs) and intermediates at the site. Distribution and sale of materials manufactured, repackaged or relabelled there were also suspended. The restrictions will remain in place until the deficiencies have been corrected and compliance has been verified through a further inspection.

Although the authority did not consider a recall necessary because no specific quality defects had been identified in marketed batches, it recommended scientifically justified testing of potentially affected materials and consideration of alternative qualified suppliers. The facility’s existing GMP certificate was withdrawn, and suspension of its certificate of suitability for bismuth subnitrate was also proposed.

09-10-2026