FDA EIR - Spectrum Laboratory Products, Inc. - August 25, 2016

An unannounced routine inspection of Spectrum Chemicals and Laboratory Products Inc. in Gardena, CA, was conducted by the FDA from August 23 to August 25, 2016. The inspection focused on the company's operations as a repacker and re-labeler of human and veterinary bulk chemicals and food additives, including United States Pharmacopeia (USP), National Formulary (NF), and Food Chemical Codex (FCC) grade materials. The regulatory framework for this inspection was based on relevant Good Manufacturing Practices (GMPs) and conducted in accordance with CPGM 7356.002B (Drug Repackers and Relabelers). The inspection evaluated the firm's Quality, Facilities and Equipment, Packaging and Labeling, and Materials systems. Notably, the inspection concluded without any significant violations or objectionable conditions. No FDA Form 483, Inspectional Observations, was issued to the firm, indicating compliance with the assessed regulatory standards. Consequently, no direct corrective actions were required from this specific inspection. However, the report noted an ongoing Level 2 recall initiated by the company's New Brunswick, NJ site for Zinc Acetate, USP, due to lead levels exceeding USP monograph limits. Actions for this recall included mailing notifications to consignees, making direct phone calls, and informing the FDA, showcasing the company's broader commitment to quality control and response mechanisms.