# Carolina Liquid Chemistries Corp – FDA 483, Feb 17, 2026

Source: https://www.keypedia.com/records/483/carolina-liquid-chemistries-corp/213da9a1-7ccd-4dc4-91dc-6efe788fcc5f

> FDA 483 for Carolina Liquid Chemistries Corp on February 17, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Carolina Liquid Chemistries Corp
- Inspection Date: 2026-02-17
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Carolina Liquid Chemistries Corp in Brea, CA, a manufacturer, repackager, and relabeler, revealed significant deficiencies in their quality management system. Observations included inadequate risk management documentation, specifically incomplete FMEAs for reagent product lines, and a misrepresentation of residual risks. The firm also failed to establish adequate procedures for timely complaint handling, lacking guidance for identifying product defects and conducting complete Medical Device Reporting (MDR) assessments. Furthermore, the company did not adequately verify purchased finished bulk products, such as Gamma-Glutamyl Transferase (GGT), against specified requirements before repackaging and relabeling.

## Related Documents

- [WARNING_LETTER - 2018-11-09](https://www.keypedia.com/records/warning_letter/carolina-liquid-chemistries-corp/6fd203c2-8614-4257-b55d-641c0a45a76b) — date: November 9, 2018

## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.keypedia.com/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)

Company: https://www.keypedia.com/companies/carolina-liquid-chemistries-corp/198c769d-4316-4edc-8d06-346ba7a406c1

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b