# FDA 483 - CAIRE DIAGNOSTICS INC - August 03, 2021

Source: https://www.keypedia.com/records/483/caire-diagnostics-inc/406fae50-13b9-48be-9796-aa43e0812be0

> FDA 483 for CAIRE DIAGNOSTICS INC on August 03, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CAIRE DIAGNOSTICS INC
- Inspection Date: 2021-08-03
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: CAIRE DIAGNOSTICS INC in Pleasanton, CA, a medical device manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately investigate customer complaints, maintain device history records, and establish proper corrective and preventive action procedures. Additionally, procedures for identifying product during various stages were not established, leading to commingling of rejected and accepted raw materials.

## Related Officers

- [Eileen M. Malecki](https://www.keypedia.com/people/eileen-m-malecki/775204bb-a174-4bf9-93dc-03c300f81af0)
- [investigator](https://www.keypedia.com/people/maida-henesian/cd28e878-000c-4af8-8dbd-4863057758bb)
- [investigator](https://www.keypedia.com/people/elizabeth-a-dakan/f701338d-0484-431b-8bd5-9db442b5f079)

Company: https://www.keypedia.com/companies/caire-diagnostics-inc/3b9b4f10-825c-45d9-b27a-2a56d2fd7d11

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b