# FDA 483 - Patrin Pharma, Inc. - October 18, 2022

Source: https://www.globalkeysolutions.net/records/483/patrin-pharma-inc/999fe99a-91a8-48e0-a0bb-f1d520372b13

> FDA 483 for Patrin Pharma, Inc. on October 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patrin Pharma, Inc.
- Inspection Date: 2022-10-18
- Product Type: device
- Office Name: Chicago District Office
- Summary: Patrin Pharma, Inc., a medical device specification developer in Niles, IL, was cited with three repeat observations during an FDA inspection. The firm failed to establish adequate procedures for design control, corrective and preventive actions, and complaint handling. These deficiencies led to issues such as uncleared pathogen-inhibiting claims on H-Chlor device labeling and inadequate investigation of product complaints.

## Related Documents

- [483 - 2019-05-06](https://www.globalkeysolutions.net/records/483/patrin-pharma-inc/af49155b-2004-4db9-bc0c-9d426915a779)

## Related Officers

- [Nicholas Z. Lu](https://www.globalkeysolutions.net/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.globalkeysolutions.net/companies/patrin-pharma-inc/c6f65be4-6fd0-4729-bd50-72475c4e18b9

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669