# FDA 483 - Lentigen Technology, Inc. - June 24, 2026

Source: https://www.keypedia.com/records/483/lentigen-technology-inc/3db94bb2-aeda-4c5d-8bd5-53d83690517b

> FDA 483 for Lentigen Technology, Inc. on June 24, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lentigen Technology, Inc.
- Inspection Date: 2026-06-24
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Lentigen Technology Inc. in Gaithersburg, MD, a drug substance intermediate manufacturer, was cited for failing to fully evaluate discrepancies involving bioburden excursions. The firm's risk assessment was found deficient in evaluating microbial contamination events that occurred during the manufacture of lentiviral products for commercial use, specifically omitting an Out of Specification (OOS) event related to a bioburden excursion.

## Related Documents

- [483 - 2024-05-03](https://www.keypedia.com/records/483/lentigen-technology-inc/91dad08f-8711-4573-a8ac-d07484568fd1)

## Related Officers

- [investigator](https://www.keypedia.com/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)

Company: https://www.keypedia.com/companies/lentigen-technology-inc/ae34d1ab-558e-45be-b9f8-e143be76e70d

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64