# FDA 483 - Apnea Sciences Corporation - August 19, 2021

Source: https://www.keypedia.com/records/483/apnea-sciences-corporation/1a1c176a-f651-429c-9b73-6f7420db3772

> FDA 483 for Apnea Sciences Corporation on August 19, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apnea Sciences Corporation
- Inspection Date: 2021-08-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Apnea Sciences Corporation, a medical device manufacturer in Aliso Viejo, CA, was inspected by the FDA from August 16-19, 2021. The inspection revealed significant deficiencies in their quality system, specifically regarding corrective and preventive actions, device history records, and acceptance activities documentation. These issues indicate a lack of adherence to established procedures and regulatory requirements for medical device manufacturing.

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)
- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/apnea-sciences-corporation/394de9b9-5b34-48ef-9b5e-55953044a180

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