# FDA 483 - Clongen Laboratories LLC - Unknown Date

Source: https://www.keypedia.com/records/483/clongen-laboratories-llc/d38e9fee-cb96-4690-958f-6ed07a122efd

> 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: Clongen Laboratories, LLC, a release testing facility in Gaithersburg, MD, received a Form 483 with six observations. The inspection revealed significant deficiencies in quality oversight, lack of written procedures for critical tasks, unqualified and unmonitored equipment, and inadequate quality control documentation and practices. Additionally, issues with employee training and the absence of a quality agreement for mycoplasma release testing were noted.

## Related Documents

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- [483 - Unknown Date](https://www.keypedia.com/records/483/clongen-laboratories-llc/bc1f40df-f34d-4d87-b2c1-b08f743490d8)

## 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)
- [Hyeon Kong](https://www.keypedia.com/people/hyeon-kong/c5da2b80-678f-41c8-9959-538fe642b44a)

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