# FDA 483 - Clongen Laboratories LLC - Unknown Date

Source: https://www.keypedia.com/records/483/clongen-laboratories-llc/ea83960f-4072-44b4-9002-bdce8796daa4

> FDA 483 for Clongen Laboratories LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Clongen Laboratories LLC
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Clongen Laboratories, LLC, a release testing facility in Gaithersburg, MD, revealed significant deficiencies across multiple areas of their operations. The firm was cited for inadequate quality oversight, a lack of written procedures for critical tasks, and failure to qualify and monitor equipment for its intended use. Additional observations included inadequate quality control documentation and practices, insufficient employee training, and the absence of a quality agreement with a third-party testing partner.

## Related Officers

- [Hyesuk Kong](https://www.keypedia.com/people/hyesuk-kong/5bcb1232-cfd1-4f32-8b5b-1ada708b77ba)
- [Carl A. Perez](https://www.keypedia.com/people/carl-a-perez/a7214b90-7632-4aff-8afb-33f1d7e7917d)
- [investigator](https://www.keypedia.com/people/kevin-j-matthews/ee27a58a-3d45-4ac6-979f-7659067c11e6)
- [Donald B. Ertel](https://www.keypedia.com/people/donald-b-ertel/f5589062-4790-47df-8763-09aba06af4d6)

Company: https://www.keypedia.com/companies/clongen-laboratories-llc/a098ae6d-0c31-46eb-ba5a-46e7ec885998

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