Isis Services, LLC – FDA Warning Letter, Apr 7, 2011

An FDA inspection of ISIS Services, LLC in San Carlos, CA, from March 22 to April 7, 2011, revealed serious violations of 21 CFR Part 58, Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. The inspection focused on studies involving the NanoKnife System. Key deficiencies included the failure to ensure personnel had adequate education, training, and experience, and to maintain comprehensive training records and CVs for individuals involved in studies, as required by 21 CFR 58.29. Testing facility management and study directors failed to fulfill their responsibilities (21 CFR 58.31, 58.33), including allowing sponsors to designate study directors, not providing proper instructions to personnel, and failing to ensure all raw data, final reports, and correspondence were transferred to archives. The Quality Assurance Unit (QAU) failed to ensure no unauthorized deviations from protocols/SOPs and to review final study reports for accuracy (21 CFR 58.35), with no documentation of QAU review for several reports and issues with contributing scientist documentation. The facility also failed to retain final study reports (21 CFR 58.190) and lacked a sufficient number of animal rooms for proper quarantine (21 CFR 58.43). ISIS Services, LLC must provide a written response within fifteen working days detailing corrective actions, including updated SOPs, training documentation, an updated master schedule of studies, and a revised facility floor plan. Failure to comply could result in regulatory action, including disqualification.