What happened
Following an inspection ending 27 August 2026, the Spanish NCA identified nine deficiencies: one critical and eight major. The critical deficiency concerned repackaging and relabelling bismuth subsalicylate from a Chinese manufacturer operating outside the EU GMP framework. OCB assigned new batch numbers, copied supplier results into certificates of analysis, replaced or removed original labels, and distributed material without adequately preserving manufacturer identity and supply-chain traceability. Major deficiencies affected investigations, CAPA, risk management, data integrity, personnel qualification, materials traceability, contamination controls, cleaning, facilities, documentation and quality oversight. The NCA temporarily suspended all API and intermediate manufacturing at Canovelles and suspended distribution and sale of material manufactured, repackaged or relabelled there, pending correction and verification through reinspection. No recall was considered necessary because no specific defects in marketed batches were detected. The NCA said suspension of the site’s bismuth subnitrate CEP should be considered. It also withdrew the current GMP certificate and recommended justified testing by customers, alternative qualified sources, and exclusion from new or ongoing applications while the statement remains in force.
Why it matters
The findings raise concerns about whether API identity, origin and analytical documentation can be reliably established throughout the supply chain. Weak contamination controls, recurring environmental-monitoring excursions, deficient cleaning and HVAC controls, and inadequate investigations may have reduced assurance against contamination or cross-contamination. The manufacturing and supply suspensions restrict use of the Canovelles site until remediation is verified, while the recommended testing and alternative sourcing measures are intended to address product-quality and supply risks.
Key topics: Repackaging and relabelling obscured the original bismuth subsalicylate manufacturer and batch traceability, Deficient HVAC, cleaning and environmental controls raised contamination and cross-contamination concerns, Manufacturing and supply were suspended pending remediation and successful reinspection
Report details
- Report number: NCF-II/NC2026/01/CAT
- EudraGMDP document reference: 187807
- Site: Ocb Pharmaceutical S.R.L.
- Country: Spain
- Inspection end date: 2026-08-27
- Issue date: 2026-09-28
Source: EudraGMDP – Statement of GMP Non-Compliance. Report number: NCF-II/NC2026/01/CAT; document reference: 187807.