# Lucin Organics, LLC – FDA 483, Jul 15, 2026

Source: https://www.keypedia.com/records/483/lucin-organics-llc/7c50d5b5-c741-4292-9080-8a48ba88645c

> FDA 483 for Lucin Organics, LLC on July 15, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lucin Organics, LLC
- Inspection Date: 2026-07-15
- Product Type: drugs
- Office Name: Denver District Office
- Summary: LUCIN ORGANICS LLC in Broomfield, CO, received a Form 483 with six observations indicating severe deficiencies across its quality system, production, laboratory controls, and facilities. The firm lacks fundamental quality unit oversight, essential documentation like batch records and CAPA, process and cleaning validations, and adequate laboratory testing and stability programs for its OTC drug products. These issues represent a systemic failure to operate under current Good Manufacturing Practices (CGMP).

## Related Officers

- [Rodney L. Tinzie](https://www.keypedia.com/people/rodney-l-tinzie/6f2bba0d-14c2-4eb5-b6a0-ececb5d7d162)

Company: https://www.keypedia.com/companies/lucin-organics-llc/39f8345a-bc73-46cc-a904-f741c785effa

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face