Spectrum Laboratory Products, Inc. – FDA EIR, Nov 16, 2018

An FDA inspection of Spectrum Laboratory Products, Inc. in Gardena, CA, was conducted from November 8-16, 2018. This inspection was a routine surveillance under current good manufacturing practice (cGMP) for drug repackagers and relabelers (Compliance Program 7356.002B) and active pharmaceutical ingredient (API) processes (7356.002F), and included an Opioid Quality Survey. The inspection resulted in an FDA Form 483, detailing three main objectionable conditions. Key violations included the failure to ensure proper requirements for Certificates of Analysis (COAs), as repackaged APIs lacked the original manufacturer's name, address, and original batch certificate, hindering product traceability. The firm's quality management system was also found inadequate, demonstrated by a lack of investigation into a cracked Buprenorphine HCl bottle during repackaging and the absence of root cause analyses or corrective actions for several customer complaints. Lastly, issues were identified with relabeling practices, specifically the failure to maintain traceability to the original manufacturer when labels were removed. Management at Spectrum Laboratory Products committed to providing a written response to the FDA within 15 business days to address these observations.