Histo-Scientific Research Laboratories (HSRL) – FDA EIR, May 8, 2006

An FDA Good Laboratory Practice (GLP) inspection of Histo-Scientific Research Laboratories (HSRL), located at 5930 Main St, Mt. Jackson, VA, was conducted on May 8, 2006. This inspection, carried out under regulatory framework CP 7348.808 from CDER's Division of Scientific Investigations, focused on HSRL's non-clinical laboratory operations. The inspection process included a facility tour, observation of laboratory activities, and review of Standard Operating Procedures (SOPs), staff training records, equipment, and data from selected protocols. During the closeout meeting, one item for discussion was the incomplete documentation of test article listings within certain firm records, specifically noting entries like "not provided by sponsor." Despite this observation, no formal FDA 483 form, which lists objectionable conditions, was issued, and no refusals or sample collections occurred. Consequently, the inspection was classified as "No Action Indicated (NAI)," indicating that no significant regulatory violations requiring corrective actions were identified by the FDA at the time of the inspection.