# FDA 483 - Premier  Laboratory, LLC - Unknown Date

Source: https://www.keypedia.com/records/483/premier-laboratory-llc/71c8b356-4cd4-4073-81e5-d615298afb20

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

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## Details

- Record Type: 483
- Company Name: Premier  Laboratory, LLC
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Premier Laboratory, LLC, a contract testing facility in Longmont, CO, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate quality system controls, including poor management of deviations, OOS, and CAPAs, insufficient quality oversight for product identity and purity, and a lack of proper employee training. Additionally, the firm failed to adequately manage suppliers and ensure equipment qualification and monitoring.

## Related Documents

- [483 - 2025-05-14](https://www.keypedia.com/records/483/premier-laboratory-llc/0d65902f-4953-441b-a7db-870b8a04da33)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd