# FDA 483 - Med Labs Inc - August 20, 2024

Source: https://www.globalkeysolutions.net/records/483/med-labs-inc/763aafdb-675a-4dc8-9d81-d230733d7275

> FDA 483 for Med Labs Inc on August 20, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Med Labs Inc
- Inspection Date: 2024-08-20
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/med-labs-inc/26f00575-8e01-45af-b6be-550f3ea0887c

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