Neotropix, Inc. (Malvern, PA, www.neotropix.com), a biotechnology company dedicated to the development and commercialization of virus-based therapeutics for the treatment of cancer and other diseases, received a warning letter on March 23, 2007, citing deviations from good laboratory practices (GLP) regulations governing the proper conduct of nonclinical studies as published under 21 CFR Part 58.
The letter describes the results of an FDA inspection that was conducted as part of the agency's Bioresearch Monitoring Program, which includes inspections designed to review research involving investigational products. The applicable provisions of the CFR cited for each violation included:
- Failure to monitor each study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls were in conformance with FDA GLP regulations, and failure to inspect each nonclinical laboratory study at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection. [21 CFR 58.35(a) and 5.35(b)(3)].
- Failure to have written standard operating procedures (SOPs) setting forth nonclinical laboratory study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. [21 CFR 58.81(a)].
According to the letter six SOPs contained nothing but the phrase “To be developed at some time in the future.” The letter also said that “six other SOPs were approved for use but appeared to be in draft condition because of the existence of many handwritten annotations made by the quality assurance unit (QAU).” The letter also advised the company that the failure to implement effective corrective actions and commission of further violations might result in the FDA taking regulatory action without further notice.