# FDA 483 - Vitti Labs, LLC - December 20, 2021

Source: https://www.keypedia.com/records/483/vitti-labs-llc/1a55d2f0-12e2-4bc0-9fd9-48aafabf735d

> FDA 483 for Vitti Labs, LLC on December 20, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vitti Labs, LLC
- Inspection Date: 2021-12-20
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Vitti Labs, LLC in Liberty, MO, was inspected by the FDA from December 6-20, 2021, as a biological drug manufacturer. The inspection revealed significant deficiencies in aseptic processing validation, production and process controls, laboratory records, and environmental controls for its injectable, ophthalmic, and topical products derived from human umbilical cord and amniotic membrane. These issues indicate a lack of adequate procedures to ensure product sterility, quality, and purity.

## Related Documents

- [WARNING_LETTER - 2021-12-20](https://www.keypedia.com/records/warning_letter/vitti-labs-llc/1da82eb5-852f-488f-9b98-138058363c02)

## Related Officers

- [Eric T. Huebler](https://www.keypedia.com/people/eric-t-huebler/a3461591-1bf1-421c-9aef-e8271a2b8547)
- [William F. Lagud](https://www.keypedia.com/people/william-f-lagud/c90c4bd6-bb56-4a60-a5f8-cbc648bb8dbe)

Company: https://www.keypedia.com/companies/vitti-labs-llc/d4b6cc08-4904-4caf-ba28-ad1c8bf74a74

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8