According to a document published yesterday a Food and Drug Administration (FDA) inspection team that visited Exemplar's facility in Fall River, Massachuesetts in April found that testing procedures used at the site were not sufficient to determine if the aerosol-based drugs made there are properly mixed.
FDA investigators Edmund Mrak Jr and Maya Davis wrote that: “Your firm [Exemplar] lacks process control on your pressurized filling system to assure content uniformity from beginning to end of filling operations” adding that “you do not prevent propellant loss due to evaporation and concomitant increase in drug substance concentration.”
Mrak Jr and Davis also said Exemplar lacked key documents, explaining that: “There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess.”
“Your firm does not have a mechanism to assure that total content specifications are met when product flow and/or pressure is disturbed” they continued before citing several specific examples.
The 483 is obviously a blow for Exemplar but it may have wider implications for industry as the firm is one of only a handful of contract development and manufacturing organisations (CDMO) with capabilities in aerosol development.
Recent problems at Boehringer Ingelheim’s CMO Ben Venue – which caused significant drug shortages - and Inyx’s financial difficulties a few years back – which forced several major pharmas to find alternate suppliers - highlight the key role that niche contractors play in the drug industry.
Exemplar has not yet responded to the 483 or to Outsourcing-pharma.com’s request for additional information.