# FDA 483 - Premier  Laboratory, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/premier-laboratory-llc/5a3124b1-47f4-460e-a5ba-3d818fefbf2a

> FDA 483 for Premier  Laboratory, LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Premier  Laboratory, LLC
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Premier Laboratory, LLC, a contract testing facility in Longmont, CO, was inspected by the FDA from May 12-14, 2025. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate management of deviations and CAPAs, insufficient quality oversight for product identity and purity, lack of proper GMP training, deficient supplier management, and unqualified or unmonitored equipment. These issues indicate a systemic breakdown in quality control and compliance with good manufacturing practices.

## Related Documents

- [483 - 2025-05-14](https://www.keypedia.com/records/483/premier-laboratory-llc/0d65902f-4953-441b-a7db-870b8a04da33)
- [483 - Unknown Date](https://www.keypedia.com/records/483/premier-laboratory-llc/71c8b356-4cd4-4073-81e5-d615298afb20)

## Related Officers

- [Nicole M. Li](https://www.keypedia.com/people/nicole-m-li/cfffdaa1-4ed3-43a3-81fc-03ddc459c564)
- [Lead Biologist](https://www.keypedia.com/people/jin-sung-hong/c1442e69-a994-4b70-8666-8b77485f63c7)
- [Review Scientist](https://www.keypedia.com/people/wen-j-seeto/ae67e12e-0785-4fe1-8da0-938499ef90f3)

Company: https://www.keypedia.com/companies/premier-laboratory-llc/88fb663e-d88f-4ac3-a008-7f04bd93e5e0

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4