FDA EIR - BioSpectra, Inc. - August 01, 2017

This FDA surveillance inspection of BioSpectra, Inc., an active pharmaceutical ingredient (API) and excipient manufacturer in Bangor, PA, was conducted from July 31 to August 1, 2017. The inspection, performed under current Good Manufacturing Practices (cGMP) regulations, focused on the company's Quality, Production, Materials, and Laboratory Systems. BioSpectra manufactures APIs like Potassium Bromide, Tromethamine, and Urea, primarily for research and development, as they are not currently utilized in approved commercial drug products. A significant outcome of this inspection was that no Form FDA 483, Inspectional Observation, was issued, indicating that no major regulatory violations were identified. The report noted that the firm had successfully implemented corrective actions from a previous 2015 inspection. Areas identified for the company's ongoing improvement included the absence of an air handling system in the raw material sampling booth and the lack of fully implemented audit trails and challenged security controls for certain laboratory instruments like the ICP-MS and HPLC during qualification. BioSpectra management indicated they were in the process of addressing these observations by implementing audit trails and installing an air system in the sampling room. No samples were collected, and no refusals were encountered during the inspection.