# FDA 483 - CPAPNEA Medical Supply - July 30, 2019

Source: https://www.globalkeysolutions.net/records/483/cpapnea-medical-supply/f5581db3-78cd-4944-ad5f-cc7b9b237a79

> FDA 483 for CPAPNEA Medical Supply on July 30, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CPAPNEA Medical Supply
- Inspection Date: 2019-07-30
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: CPAPNEA MEDICAL SUPPLY, a medical device manufacturer in Phoenix, AZ, was inspected by the FDA. The inspection revealed a severe lack of fundamental quality system procedures, with nine observations citing the absence of established processes for critical activities such as corrective and preventive actions, complaint handling, design control, and device history records. This indicates a systemic failure to implement basic regulatory requirements for medical device manufacturing.

## Related Documents

- [WARNING_LETTER - 2019-07-30](https://www.globalkeysolutions.net/records/warning_letter/cpapnea-medical-supply/24f20b1b-30a2-4e73-ba3c-5982009db496)
- [483 - 2020-10-07](https://www.globalkeysolutions.net/records/483/cpapnea-medical-supply/112acc02-527e-4ecf-bb53-c39a50847a3b)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/cpapnea-medical-supply/f95eb2b6-59f6-4e63-b8cc-0da9f1d3543e

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