FDA served U.K.-based Porton Biopharma a warning letter after an inspection revealed failures to notify the agency of changes affecting drugs, and failing to follow procedures to prevent microbiological contamination.
A March 2016 inspection of Porton’s London facility revealed deficiencies that persisted following discussion during a regulatory meeting between the agency and the firm in late 2015 — including a lack of environmental monitoring within the Restricted Access Barrier Systems, and not using a sporicidal disinfectant on surfaces inside an aseptic filling room, even though the firm’s environmental monitoring had detected spore-forming organisms.
The agency also discovered new deficiencies, including a floor exhaust vent used to remove air entering the filling room that was blocked by ancillary equipment during media fill simulations. Inspectors also found inadequate validation of a sterilization cycle used on equipment to be transferred to an aseptic filling room.