# FDA 483 - CPAPNEA Medical Supply - October 07, 2020

Source: https://www.keypedia.com/records/483/cpapnea-medical-supply/112acc02-527e-4ecf-bb53-c39a50847a3b

> FDA 483 for CPAPNEA Medical Supply on October 07, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CPAPNEA Medical Supply
- Inspection Date: 2020-10-07
- Product Type: device
- Office Name: Denver District Office
- Summary: CPAPNEA Medical Supply, a manufacturer of the Class 1 Optipillows EPAP Mask, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for corrective and preventive actions, device master records, and design controls. These issues indicate a fundamental lack of compliance with medical device quality system requirements.

## Related Documents

- [483 - 2019-07-30](https://www.keypedia.com/records/483/cpapnea-medical-supply/f5581db3-78cd-4944-ad5f-cc7b9b237a79)
- [WARNING_LETTER - 2019-07-30](https://www.keypedia.com/records/warning_letter/cpapnea-medical-supply/24f20b1b-30a2-4e73-ba3c-5982009db496)

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

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

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face