# FDA 483 - MEDIPINES CORPORATION - January 22, 2024

Source: https://www.keypedia.com/records/483/medipines-corporation/97c20050-d3bb-4528-9e38-862c7c30ea2e

> FDA 483 for MEDIPINES CORPORATION on January 22, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MEDIPINES CORPORATION
- Inspection Date: 2024-01-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of MEDIFINES CORPORATION in Yorba Linda, CA, a manufacturer of the AGM 100 oximeter, revealed significant deficiencies in its quality system. The firm failed to adequately validate manufacturing processes, establish proper complaint handling procedures, and ensure the effectiveness of its corrective and preventive actions. These issues indicate a lack of control over critical aspects of medical device production and post-market surveillance.

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/medipines-corporation/42f7628a-6840-4ea6-ae39-9b9632608320

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