# FDA 483 - Lentigen Technology, Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/lentigen-technology-inc/91dad08f-8711-4573-a8ac-d07484568fd1

> FDA 483 for Lentigen Technology, Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lentigen Technology, Inc.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Lentigen Technology, Inc. in Gaithersburg, MD, identified significant deficiencies in the testing and qualification of raw materials used in the manufacturing of their MAGE-A4-c1032 lentiviral vector. The firm failed to adequately test and qualify critical raw materials and consumables, including issues with Certificate of Analysis testing and visual inspection procedures. These observations indicate a lack of robust quality control over essential manufacturing inputs.

## Related Officers

- [Sharmila Shrestha](https://www.globalkeysolutions.net/people/sharmila-shrestha/0a91aac0-76a5-4105-a23b-e0966f1aec0e)
- [ Investigator, Consumer Safety Officer](https://www.globalkeysolutions.net/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Christine Hamer](https://www.globalkeysolutions.net/people/christine-hamer/71d59456-6cdb-481f-b89b-0e23d5eb1460)
- [Alan G. Baer](https://www.globalkeysolutions.net/people/alan-g-baer/bd794982-d4e0-4b9d-831b-5daa05edda54)
- [Laura DeMaster](https://www.globalkeysolutions.net/people/laura-demaster/e3100cd3-a0fe-4d17-ae22-d5b516b5b25a)

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

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