# FDA 483 - AeroBiotix LLC - March 09, 2022

Source: https://www.globalkeysolutions.net/records/483/aerobiotix-llc/85ba4ea9-aa3f-4f92-a602-b876d4a3b1da

> FDA 483 for AeroBiotix LLC on March 09, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AeroBiotix LLC
- Inspection Date: 2022-03-09
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: AeroBiotix LLC, a medical device manufacturer in Miamisburg, OH, was cited for two significant issues during an FDA inspection. The firm failed to perform software validation for its Class II medical devices and lacked adequate procedures for product identification throughout its manufacturing and warehousing processes. These observations indicate deficiencies in design controls and quality system procedures.

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.globalkeysolutions.net/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)

Company: https://www.globalkeysolutions.net/companies/aerobiotix-llc/339f8608-64ad-4a13-9704-3a3e491373eb

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