Carlsbad Technology, Inc – FDA 483, Jun 30, 2026

Carlsbad Technology, Inc., a drug manufacturer in Carlsbad, CA, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results and customer complaints, lacking identified root causes and effective corrective actions. Additionally, the quality control unit did not adequately follow procedures for equipment logbooks, supplier qualification audits, and the disposition of out-of-specification materials, and the company failed to perform analytical verification of shared equipment cleaning, raising concerns about potential cross-contamination of drug products.