# FDA 483 - NANOFIBER SOLUTIONS, INC - October 29, 2021

Source: https://www.globalkeysolutions.net/records/483/nanofiber-solutions-inc/8efcdf8f-7776-4b39-9854-b1686d04ca29

> FDA 483 for NANOFIBER SOLUTIONS, INC on October 29, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: NANOFIBER SOLUTIONS, INC
- Inspection Date: 2021-10-29
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: NANOFIBER SOLUTIONS, INC in Dublin, OH, underwent an FDA inspection from October 25-29, 2021. The inspection resulted in one observation concerning inadequate process validation. Specifically, the firm failed to routinely perform Operational Qualification for critical foil pouch and sealing processes used for sterile medical devices.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/javonica-f-penn/56294265-08fc-4d1d-8a34-626fc4dad457)

Company: https://www.globalkeysolutions.net/companies/nanofiber-solutions-inc/63361ac1-b92d-449e-8849-47aa8a76f076

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