# FDA 483 - Colgin, Inc - September 21, 2023

Source: https://www.globalkeysolutions.net/records/483/colgin-inc/a98d3544-1983-44af-ab64-aac4a33f8652

> FDA 483 for Colgin, Inc on September 21, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Colgin, Inc
- Inspection Date: 2023-09-21
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Colgin, Inc., a drug manufacturer in Dallas, TX, was cited for significant deficiencies in its quality control unit, manufacturing processes, and facility maintenance during an FDA inspection. The firm failed to follow written procedures, validate processes, test raw materials and finished products, and used expired ingredients, indicating a severe lack of cGMP adherence. The facility also showed poor sanitation and equipment maintenance.

## Related Officers

- [Alan A. Rivera](https://www.globalkeysolutions.net/people/alan-a-rivera/4bec02c3-c62e-4b3a-a6ab-02c3386549bf)

Company: https://www.globalkeysolutions.net/companies/colgin-inc/563cd553-373b-43fa-b237-cf503a84ce94

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab