# FDA 483 - Clongen Laboratories LLC - Unknown Date

Source: https://www.keypedia.com/records/483/clongen-laboratories-llc/bc1f40df-f34d-4d87-b2c1-b08f743490d8

> 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: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Clongen Laboratories, LLC in Gaithersburg, MD, a release testing facility, revealed significant deficiencies in quality oversight, written procedures, equipment qualification, and quality control practices. The firm also lacked adequate employee training and a critical quality agreement for mycoplasma release testing. These findings indicate a broad failure to maintain a state of control over laboratory operations.

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## Related Officers

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

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

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