FDA EIR - BioSpectra, Inc. - May 04, 2021

An FDA surveillance Good Manufacturing Practice (GMP) inspection was conducted at BioSpectra, Inc. in Roseto, PA, from April 29 to May 4, 2021. The inspection, focusing on non-sterile active pharmaceutical ingredients (APIs) and excipient manufacturing for both human and veterinary use (under Compliance Program 7371.001 and ICH Q7 guidance), identified several deficiencies, although no formal FDA-483 observations were issued. Key issues verbally discussed with management included the improper storage of waste totes containing aqueous solutions in cleaned API suites, which posed a potential contamination risk. Investigators also noted an inadequate investigation into temperature and humidity excursions in a stability chamber, specifically the absence of a product impact assessment for stored samples. Furthermore, a gap was identified in the SOP training for a QA Compliance Specialist performing Environmental Monitoring functions, and a production equipment logbook lacked proper initials and dates for preventative maintenance entries, hindering traceability. BioSpectra's management acknowledged these concerns during the closeout meeting and committed to implementing voluntary corrective actions to address all verbally discussed items. No samples were collected, and no refusals were encountered during the inspection.