Problems with quality management, data integrity, expired raw materials and more have prompted the European Medicines Agency (EMA) to put the kibosh on manufacturing at Serra Pamies’ Reus, Spain, facility.
After inspecting the plant in May and June, the Spanish Agency of Medicines and Medical Devices said it uncovered 63 total deficiencies, 19 of which were classified as “major.”
Alongside issues with quality, data and raw materials, investigators pinpointed problems with software validations, qualification of manufacturing and control clean areas as well as “the analysis and release of Morphine” and analysis of endotoxins, the Spanish regulator said.
The Spanish medicines agency also accused Serra Pamies of deficiency in “the management of donations and in self-inspections.”
Serra Pamies did not immediately respond to Fierce Pharma’s request for comment.
Because of the company’s production slights, manufacturing “has already been suspended as a precautionary measure,” according to a public report from the Spanish medicines agency.
The manufacturing hold covers liquids, capsules, tablets and other solid pharmaceuticals for both human and animal use.
“This measure has [been] adopted due to the possible risk to animal/public health that may occur as a result of the criticality of the deficiencies identified during the inspection,” the report states.
The EMA will keep the hold in place until all deficiencies outlined in the report have been addressed and verified through another inspection.
In the meantime, Serra Pamies is also banned from selling any injectable, oral solid, or liquid medicine that has been manufactured at the company’s facilities.
The Spanish medicines agency pointed out that it found “no specific quality defects on concrete batches present in the market.” As a result, no recalls will occur in tandem with the production halt.
Serra Pamies was established back in 1885 by the Reus pharmacist and philanthropist Antonio Serra Pamies, initially focusing on manufacturing medicinal plant extracts. Then the company nabbed the right to produce aspirin in Spain in the 1920s.
At the end of the 20th century, the company “faced the enormous challenges in the pharmaceutical industry,” Serra Pamies says on its website.
Things took a turn in 2001, when Serra Pamies opened a new production plant, which it calls a “pioneer” in applying “new, quality technologies to the production process.”
Serra Pamies says it boasts a footprint of more than 6,000 square meters, with facilities that comply with “strict GMP international standards and guarantee the quality of our products and processes.”