483
Med Labs IncFDA 483 - Med Labs Inc - August 20, 2024
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An FDA inspection of Med Labs Inc in Goleta, CA, conducted from August 19-20, 2024, identified one significant observation. The firm failed to ensure that the labels of their Class II medical devices, specifically muscle simulators and a portable alarm, bore unique device identifiers (UDI) as required by regulations. This indicates a non-compliance with UDI labeling requirements for their medical devices.
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ID · 763aafdb-675a-4dc8-9d81-d230733d7275