# FDA 483 - Gateway Analytical, LLC. - March 20, 2026

Source: https://www.keypedia.com/records/483/gateway-analytical-llc/f7eb323d-00ce-44a3-95c7-94a24679639c

> FDA 483 for Gateway Analytical, LLC. on March 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gateway Analytical, LLC.
- Inspection Date: 2026-03-20
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Gateway Analytical, LLC, a contract laboratory in Gibsonia, PA, was cited for failing to follow written procedures for the cleaning and maintenance of equipment. Specifically, a critical freezer used for storing analytical samples experienced multiple temperature excursions due to overdue preventative maintenance, without scientific justification. This indicates a significant lapse in maintaining controlled storage conditions for customer samples.

## Related Documents

- [EIR - 2015-01-15](https://www.keypedia.com/records/eir/gateway-analytical-llc/a3ce0334-354b-462e-b57c-bdee4ba565a6)
- [EIR - 2021-04-14](https://www.keypedia.com/records/eir/gateway-analytical-llc/2850461f-c91e-4610-9a9d-88d5fa45cb75)
- [EIR - 2022-09-16](https://www.keypedia.com/records/eir/gateway-analytical-llc/5f539d71-804b-4d73-9262-e4236a4b5531)

## Related Officers

- [Kara J. Wright](https://www.keypedia.com/people/kara-j-wright/d12b6a4f-9710-4811-b1b2-5ff5f9342155)

Company: https://www.keypedia.com/companies/gateway-analytical-llc/9ef2f86f-03e6-464f-85c4-35a2ef6d82b9

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8