# FDA 483 - Apneicare LLC dba Patient Safety Inc. - August 23, 2022

Source: https://www.keypedia.com/records/483/apneicare-llc-dba-patient-safety-inc/f6589487-f2e8-4f76-8407-a937ac0c219f

> FDA 483 for Apneicare LLC dba Patient Safety Inc. on August 23, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apneicare LLC dba Patient Safety Inc.
- Inspection Date: 2022-08-23
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Apneacare LLC dba Patient Safety Inc. in Columbus, OH, a medical device manufacturer, revealed significant deficiencies in its quality system. The firm's procedures for complaint handling, corrective and preventive actions, and design change control were found to be inadequately established. These recurring observations indicate systemic issues with documentation, verification, and consistent implementation of critical quality processes.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.keypedia.com/companies/apneicare-llc-dba-patient-safety-inc/dcf788e6-0728-42cc-b0ae-59b5ddc51343

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22