FDA EIR - BioSpectra, Inc. - January 29, 2016

This FDA inspection of BioSpectra, Inc., located in Roseto, PA, was conducted from January 28-29, 2016. This was a compliance follow-up to a previous inspection in March 2015, which resulted in a "withhold" recommendation for the company's Potassium Bromide Active Pharmaceutical Ingredient (API). The prior inspection cited several issues, including inadequate equipment qualification, insufficient traceability in blended batch records, lack of proper documentation for process validation changes, and absence of defined time limits for cleaning and cleaning verification of processing equipment.

The current inspection, guided by FDA compliance programs for Animal Drug Inspections, NADA Pre-Approval inspections, and API Process Inspections, alongside ICH Q7 guidelines, aimed to assess the firm's corrective actions. Investigators reviewed the implemented changes and confirmed that BioSpectra, Inc. had successfully addressed all previous observations. The company completed all necessary equipment qualifications, corrected batch record traceability, implemented robust change control procedures, and updated cleaning protocols for Potassium Bromide API. Consequently, no new observations were issued, and the inspector recommended approval for the GMP portion of the Potassium Bromide API pre-approval product.