# FDA 483 - CofixRX, LLC - January 20, 2023

Source: https://www.keypedia.com/records/483/cofixrx-llc/d89a05c1-46b3-49f1-b334-3ff7b9c77337

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

---

## Details

- Record Type: 483
- Company Name: CofixRX, LLC
- Inspection Date: 2023-01-20
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: CofixRX, LLC in Rochester Hills, MI, was inspected and received a Form FDA 483 with six observations. The inspection revealed significant deficiencies across multiple quality system areas, including the absence of a quality control unit, lack of stability testing, and inadequate complaint investigations. These issues indicate a fundamental lack of established procedures and oversight for drug product manufacturing and distribution.

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Joohi Castelvetere](https://www.keypedia.com/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)

Company: https://www.keypedia.com/companies/cofixrx-llc/1aa815d1-2ead-4b5e-85d7-7267d3764d78

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