- The Swedish Medical Products Agency (MPA) will withdraw the E.U. good manufacturing practice (GMP) certificate from a subsidiary of major CRO Capsugel, after finding two critical and seven major deficiencies at the Bend, Oregon site.
- Some of the issues cited include data integrity problems, validation, and hygiene issues. While the MPA did not call for a recall, it did recommend against approving any drug applications which list the subsidiary, Bend Research, as a manufacturer.
- A Capsugel spokesman told Regulatory Focus the company had initiated corrective action and hoped to address the violations quickly.
MPA’s declaration of non-compliance is somewhat of a reversal of the typical news in pharma manufacturing. Usually it is the FDA censuring a foreign manufacturing site for lack of GMP compliance, rather than a foreign regulator citing a US supplier.
According to Bend Research’s website, the facility specializes in solid oral dosage-form manufacturing.
Bend Research previously worked exclusively with Pfizer but now works with other pharma companies. Capsugel bought Bend in September 2013 to complement is dosage-form business.
The MPA report said several findings from two previous inspections in August and September last year, as well as in August 2012 had not been corrected. In addition to the critical and major violations, the MPA also found 12 other deficiencies.
Without an E.U. GMP certification, any business Bend has in supporting clinical trial applications in Europe could be hampered. No marketing authorizations or extensions to existing approvals can be supported until a new certificate is issued.