483
METRO OPTICS, INCFDA 483 - METRO OPTICS, INC - March 17, 2025
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Record Details
An FDA inspection of METRO OPTICS, INC, a manufacturer in Dallas, TX, revealed significant deficiencies in their document control procedures. The firm failed to adequately establish and follow processes for documenting and implementing changes, ensuring document suitability, and providing required audit records. These issues indicate a breakdown in their quality system for managing critical operational documents.
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ID · 06285c0e-78ec-4ec7-a71a-55b3920d30b1