Sweden’s Medical Products Agency (MPA) declared Monday that Capsugel subsidiary Bend Research’s Oregon manufacturing site does not comply with Europe’s good manufacturing practice (GMP) requirements.
The statement of non-compliance follows a 24 February inspection of the site, which uncovered non-compliant operations with regard to non-sterile products, packaging and quality control testing.
The inspection also found two critical, seven major and 12 other deficiencies at the facility. The two critical and one major issue were linked to “data integrity,” while the major deficiencies were found in the areas of validation, hygiene routines, mobile equipment in the multipurpose facilities and documentation routines.
“Several findings from the two previous MPA inspections Aug-Sep 2015 and in Aug 2012 had not been corrected,” the regulators said.
The last valid EU-GMP certificate issued by MPA, which expired in August 2015, will be withdrawn.
“It is recommended that, unless exceptionally justified, any pending Clinical Trial Applications in the EEA, listing Bend Research Inc (BRI) as a manufacturer, are not approved until a new GMP certificate has been issued,” according to the statement. “No new EEA marketing authorisation applications, line extensions or variations to existing EU marketing authorisation applications where BRI is involved as a manufacturer can be supported until a new GMP certificate has been issued.”
Despite the findings, MPA also said that a recall of batches has not been deemed necessary to date.
Capsugel spokesman Frank Briamonte told Focus: “We are working diligently to address the deficiencies identified during the MPA’s recent inspections at Bend Research. Per the MPA’s statement of May 16, 2016, no recall of batches has been deemed necessary to date. We have initiated a series of Corrective and Preventive Actions, and have retained recognized third-party consultants to verify that our systems, processes, procedures and batch releases meet EU GMP standards. We are confident that we can resolve this issue quickly so we can continue to support our customers’ ability to provide patients access to the high-quality drug products they need.”
Bend was acquired by Capsugel in 2013, and in November 2013, Capsugel invested $20 million in the site to add pharmaceutical spray drying capacity.