Products from two drugmakers are going back into production following the facility restart of contract manufacturer Aveva Drug Delivery Systems. Aveva has notified the FDA that it plans to resume manufacturing, to the relief of BioDelivery Sciences and ProStrakan.
Both brand-holders say they expect new supplies of their Aveva-manufactured products--BioDelivery's Onsolis and ProStrakan's Sancuso--to be available by March.
BioDelivery says it had sufficient stock of Onsolis, a cancer pain medication delivered via film placed inside the cheek, to carry it through the voluntary facility shutdown. Sancuso is a transdermal patch for prevention of chemotherapy-induced nausea.
The Aveva shutdown follows a late 2009 inspection of the Miramar, FL, facility, which yielded Warning Letter FLA-10-19, issued last May. Among inspector findings are inadequate written procedures for production and process controls, inadequate investigation of batch failures, instances of investigations concluded without root cause findings, and lack of investigations into process problems noted by Aveva quality inspectors. Among the latter is the failure of adhesive on transdermal patches for blood pressure control that yielded hundreds of complaints over a two-month period in 2009.
The warning letter notes also that the lack of a root cause finding in one of the company's closed investigations is a repeat violation from a 2008 inspection.