# FDA 483 - Respironics California, LLC - January 10, 2020

Source: https://www.keypedia.com/records/483/respironics-california-llc/f3653b59-0eba-4899-af6b-fec7f0bbb1da

> FDA 483 for Respironics California, LLC on January 10, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Respironics California, LLC
- Inspection Date: 2020-01-10
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Respironics California, LLC, a medical device manufacturer in Carlsbad, CA, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, leading to unaddressed issues with ventilators that resulted in patient deaths and serious injuries. Additionally, the inspection revealed late Medical Device Reports, inadequate control of nonconforming product, and failures in complaint handling and incoming product acceptance procedures.

## Related Documents

- [483 - 2021-09-10](https://www.keypedia.com/records/483/respironics-california-llc/f2f8868e-9453-4155-92e6-ab23803d5859)
- [483 - 2022-05-19](https://www.keypedia.com/records/483/respironics-california-llc/4b3dc402-b1ae-4393-9952-0672445f0869)

## Related Officers

- [Cecily M Jones](https://www.keypedia.com/people/cecily-m-jones/2f5b56b6-3473-46f9-a9ed-c4cd7b6e4658)
- [Brandon T. Blakely](https://www.keypedia.com/people/brandon-t-blakely/81d7155a-cb28-4372-9167-ec13b5676e2b)
- [Investigator](https://www.keypedia.com/people/janet-pulver/d46b01cd-8c3d-4a54-bb91-843e0f94de89)

Company: https://www.keypedia.com/companies/respironics-california-llc/b33e7127-4736-4679-b8bc-0ee712aa8835

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