# FDA 483 - Agora June LLC - April 22, 2022

Source: https://www.globalkeysolutions.net/records/483/agora-june-llc/a15f4886-0b5e-4236-8cca-0f1fa856c13e

> FDA 483 for Agora June LLC on April 22, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Agora June LLC
- Inspection Date: 2022-04-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.globalkeysolutions.net/companies/agora-june-llc/bead4e99-0c7d-46fa-97f1-8a52f0ec2753

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6