FDA 483 - Brighton Laboratory - August 21, 2025
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Optimal Solutions Inc dba Brighton Laboratory, a contract testing laboratory in Las Vegas, NV, was cited for significant quality control deficiencies during an FDA inspection from August 19-21, 2025. The firm's quality unit lacked written procedures and adequate control over documents related to OTC drug testing. Issues included using unvalidated programs for calculations, poor documentation practices in microbiology logbooks, and insufficient audit trail review for HPLC software.
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ID · 44678a06-9a3c-442a-9552-ceef9569cf00