The Medical Products Agency (MPA) outlined its concerns about the facility in a post on the EudraGMP database, citing a number of deviations from good manufacturing practices (GMP) observed during an inspection in February.
The MPA cited “data integrity” as a critical deficiency. It also reported major deficiencies relating to validation, hygiene routines, identification of mobile equipment in the multipurpose facilities and documentation.
In addition, the agency expressed concern that deficiencies observed during inspections conducted in 2013 and August last year have not been corrected.
An MPA spokesman told us "Bend Research Inc has received an inspection report and responded to it with a plan for corrective and preventive actions.
"The response has been evaluated by the MPA and judged to be partly unacceptable. After this the statement of non-compliance with GMP has been issued. The document that was withdrawn was a previously expired GMP-certificate.”
The MPA also recommended that clinical trial and marketing authorisation applications listing Bend as a manufacturer are not accepted until a new certificate has been issued.
The Swedish regulator issued a GMP certificate for the Oregon facility – which is known as BRIM and makes oral solid dose products for clinical trials and commercial supply – in 2013.
Later that Bend was acquired by Capsugel, which invested $20m in November 2013 to add commercial spray drying capacity at the Oregon site.
A Capsugel spokesman told us: “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."
According to the spokesman the facility "provides formulation development clinical and commercial manufacturing services for a wide range of dosage forms."