483
Agora June LLCFDA 483 - Agora June LLC - April 22, 2022
Record Details
Agora June, LLC, a medical device manufacturer in N Hollywood, CA, was inspected by the FDA, revealing significant deficiencies in its quality system. The firm failed to establish adequate procedures for receiving, reviewing, and evaluating complaints, including those related to Medical Device Reporting. This lack of established processes and record-keeping indicates a critical gap in their complaint handling system.
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ID · a15f4886-0b5e-4236-8cca-0f1fa856c13e