FDA 483 - Belmar Labs, LLC - May 20, 2026
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Belmar Labs, LLC, a contract testing facility in Golden, CO, received a Form 483 from the FDA following an inspection. The report details significant quality control deficiencies, including inadequate investigations into recurring incubation process failures and a failure to ensure the effectiveness of corrective actions. Additionally, the firm was cited for using unverified reference standards and for not conducting identity testing on incoming materials, raising concerns about the reliability of their testing operations.
ID · 47190be9-5646-4a30-b396-02bcce746bc7