FDA EIR - Gurunanda LLC - November 10, 2021

An FDA surveillance inspection of GURUNANDA LLC, a drug product warehousing and distribution facility in Buena Park, CA, took place from November 8-10, 2021. Operating under the Drug Process Inspections program (Compliance Program 7356.002), the assessment covered key drug systems like Quality, Production, and Facilities. A significant outcome was the finding of "no deficiencies" in the firm's current operations, with the warehouse noted as clean and adequate. Consequently, no FDA Form 483 was issued, and no corrections were formally requested. A primary focus of this inspection was to follow up on a Warning Letter issued to GURUNANDA LLC on March 6, 2020. This prior regulatory action concerned unsubstantiated claims on the company's website and social media, asserting that their products could mitigate, prevent, treat, cure, or diagnose COVID-19. Management confirmed the removal of these claims, which the investigator verified on the firm's website, demonstrating compliance with the previous requirement. While no formal violations were identified, a verbal discussion highlighted the absence of a program for annual Process Parameter and Product Quality Monitoring (PPPQM) and Annual Product Reviews (APRs), which the firm was advised to implement. Overall, the inspection confirmed GURUNANDA LLC's compliance with regulatory standards for their current warehousing and distribution activities, having resolved the critical issue from the earlier Warning Letter.