FDA 483 - Nanoimaging Services, Inc. - March 03, 2022

NANOIMAGING SERVICES INC, a laboratory in San Diego, CA, was cited for significant quality system deficiencies during an FDA inspection. Observations included the complete absence of a formal Quality Control Unit, a lack of written procedures for critical quality activities, and inadequate employee training in current good manufacturing practices. Additionally, the firm's proprietary laboratory information management system (LIMS) was found to be unvalidated.