The Serra Pamies facility located in Reus, Spain, has had its manufacturing operations halted by the European Medicines Agency (EMA) due to a variety of issues encompassing problems with quality management, concerns about data integrity, and the utilization of expired raw materials. The rationale behind this decision stems from a series of inspections carried out by the Spanish Agency of Medicines and Medical Devices during the months of May and June. This scrutiny revealed a total of 63 shortcomings, with 19 of them categorized as significant “major” issues.
In addition to the concerns related to quality control, data security, and the use of raw materials past their expiration date, the investigative team also identified complications tied to software validations, the certification of manufacturing processes, and the oversight of controlled clean areas. The Spanish regulator’s report further highlighted deficiencies in the analysis and release procedures for Morphine, as well as shortcomings in the assessment of endotoxins. Furthermore, the Spanish agency accused Serra Pamies of failing to effectively manage donations and carry out satisfactory self-inspections.
Notably, despite the situation, Serra Pamies has not provided an immediate response to inquiries from Fierce Pharma about the matter. As a pre-emptive measure, manufacturing activities have already been suspended, a move that has been detailed in a public report released by the Spanish medicine agency. This suspension encompasses the production of various pharmaceutical forms, including liquids, capsules, tablets, and other solid products designed for both human and animal usage.
The decision to enforce a manufacturing halt has been grounded in the potential risks posed to public and animal health arising from the critical deficiencies uncovered during the inspection, as elucidated in the agency’s official report. Until all the highlighted deficiencies have been addressed and validated through a subsequent inspection, the EMA will uphold this manufacturing suspension.
Throughout this interim period, Serra Pamies is also restrained from marketing any injectable, oral solid, or liquid medications that have been manufactured at its facility. Significantly, the Spanish medicines agency has underscored that no specific instances of compromised quality have been detected in the batches of products that are already available in the market. Consequently, the need for product recalls in conjunction with the manufacturing suspension has been obviated.
Serra Pamies boasts a heritage dating back to 1885 when it was established by Antonio Serra Pamies, a pharmacist and philanthropist hailing from Reus and currently has facilities spanning over 6,000 square meters.
