# FDA 483 - LXR Biotech, LLC - January 20, 2023

Source: https://www.keypedia.com/records/483/lxr-biotech-llc/2c80bf38-080f-487d-ba8f-87363329db79

> FDA 483 for LXR Biotech, LLC on January 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LXR Biotech, LLC
- Inspection Date: 2023-01-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: LXR Biotech, LLC, a manufacturer in Rochester Hills, MI, was inspected and cited for severe deficiencies in its quality control unit, laboratory controls, and production processes for drug products, specifically CofixRx Nasal Spray. The firm lacked independent quality oversight, failed to establish and follow written procedures for manufacturing and testing, and maintained incomplete batch records, indicating a fundamental breakdown in cGMP compliance.

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Jochi Castelwetere](https://www.keypedia.com/people/jochi-castelwetere/c1aaf78e-9f81-4558-9f87-d3fcf4c42d08)

Company: https://www.keypedia.com/companies/lxr-biotech-llc/f16deba5-a299-4e42-9748-d4dca1f33535

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0