# FDA 483 - Respire Medical Holdings, LLC - October 25, 2022

Source: https://www.globalkeysolutions.net/records/483/respire-medical-holdings-llc/17f68a69-2ce6-4794-825e-5d2dae3f6a20

> FDA 483 for Respire Medical Holdings, LLC on October 25, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Respire Medical Holdings, LLC
- Inspection Date: 2022-10-25
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Respire Medical Holdings, LLC, a manufacturer of sleep apnea devices in Brooklyn, NY, was cited for significant quality system deficiencies during an FDA inspection. Observations included failure to submit an MDR report for an allergic reaction, inadequate design verification, and poor supplier selection and control. Further issues involved undocumented personnel training, lack of device master record maintenance with expired raw materials, and inadequate document control procedures, indicating a broad lack of control over critical manufacturing and quality processes.

## Related Documents

- [483 - 2019-08-15](https://www.globalkeysolutions.net/records/483/respire-medical-holdings-llc/292b2fb6-79ac-448b-a8f7-a69d54ae0d59)

## Related Officers

- [Jacqueline S. Warner](https://www.globalkeysolutions.net/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.globalkeysolutions.net/companies/respire-medical-holdings-llc/1e55c420-e4dd-4c4c-ad8d-ef6f363b4526

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961