# FDA 483 - Livent USA Corp - February 03, 2020

Source: https://www.keypedia.com/records/483/livent-usa-corp/2cbe8d4c-6424-4ed4-b55b-e8921bcf0930

> FDA 483 for Livent USA Corp on February 03, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Livent USA Corp
- Inspection Date: 2020-02-03
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Livent Corporation, an Active Pharmaceutical Ingredient (API) manufacturer in Bessemer City, NC, was cited for significant deficiencies in its quality control unit, out-of-specification laboratory results procedures, and complaint handling. The inspection revealed failures in tracking corrective/preventive actions, improper retesting by initial analysts, and inadequate complaint investigation processes. These issues indicate a systemic lack of adherence to established procedures and regulatory expectations.

## Related Officers

- [Investigator](https://www.keypedia.com/people/sonya-m-edmonds/a38fad3f-f664-4c52-8e50-78782f56ff18)

Company: https://www.keypedia.com/companies/livent-usa-corp/62a57fac-fd3b-417b-bcfb-cf0122756768

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7