FDA EIR - HistoScientific Research Laboratories (HSRL), Inc. - February 07, 2017

An FDA surveillance inspection of HistoScientific Research Laboratories (HSRL), Inc., a nonclinical laboratory located in Mount Jackson, VA, was conducted on February 7, 2017. The inspection evaluated the facility's operations related to various products, including human and animal drugs, antibiotics, orthopedic, and pathology services. Under the regulatory oversight of the Food and Drug Administration, the inspection aimed to assess compliance. The overall conclusion from multiple district decisions and the OSIS reviewer was "No Action Indicated" (NAI). This signifies that no significant violations or issues were identified during the assessment. Consequently, no FDA Form 483, which details observational deficiencies, was issued to HSRL. Therefore, no specific regulatory actions or corrective measures were required from the company as a direct result of this inspection. The outcome reflects a satisfactory compliance status at the time of the inspection.