Spectrum Laboratory Products, Inc. – FDA EIR, Mar 12, 2021

An FDA inspection of Spectrum Laboratory Products, Inc., an Active Pharmaceutical Ingredient (API) repackager and relabeler in Gardena, CA, took place from March 9-12, 2021. This review was a follow-up to a Warning Letter issued in June 2019, which itself arose from an inspection in November 2018. The inspection was conducted to evaluate compliance with good manufacturing practices for drug repackagers and active pharmaceutical ingredients. The earlier inspection revealed significant issues, including failures to meet requirements for Certificates of Analysis, an inadequate quality system for investigating deviations and complaints, and non-compliance with relabeling standards. The subsequent Warning Letter specifically cited the company for not transferring quality information to customers and for its quality unit's failure to thoroughly investigate critical deviations, in addition to misbranding concerns. While the current inspection found improvements in many areas, new and persistent issues were identified. A key deficiency, recurring from the prior inspection, involved incomplete quality system investigations for customer complaints and deviations. Auditors also cited inadequate security for Quality Control Laboratory instrument software and the absence of specific written procedures for analytical test methods. Minor issues included a packer's torn hairnet and further computer system security concerns. Spectrum Laboratory Products, Inc. has committed to providing a written response to the FDA’s observations within 15 business days, outlining their corrective actions.