483
BioMed Laboratories, LLC.FDA 483 - BioMed Laboratories, LLC. - October 31, 2025
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During an inspection, BioMed Laboratories, LLC. in Dallas, TX, was cited for significant deficiencies in its OTC drug manufacturing operations. The firm failed to establish and follow adequate procedures for stability testing, component control, quality unit responsibilities, and equipment cleaning. These issues indicate a lack of robust quality systems and control over drug product manufacturing.
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ID · be3f693e-4817-4bd7-a732-37001dcd4a3d