# FDA 483 - ICON Laboratory Services, Inc. - April 25, 2024

Source: https://www.globalkeysolutions.net/records/483/icon-laboratory-services-inc/7480fc41-d13e-4456-8560-21d0042586f1

> FDA 483 for ICON Laboratory Services, Inc. on April 25, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ICON Laboratory Services, Inc.
- Inspection Date: 2024-04-25
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of ICON Laboratory Services, Inc. in Whitesboro, NY, identified a significant deviation from the firm's Standard Operating Procedures (SOPs) for LC-MS analysis. The firm failed to correctly process and report re-analysis results for study samples, including misapplying calculation rules and conducting unauthorized single repeat analyses. This indicates a moderate severity issue concerning adherence to established quality control procedures in bioanalytical testing.

## Related Documents

- [EIR - 2015-01-29](https://www.globalkeysolutions.net/records/eir/icon-laboratory-services-inc/4dc02d02-0b4f-4aa6-a745-26dcbf1b9962)
- [EIR - 2019-11-22](https://www.globalkeysolutions.net/records/eir/icon-laboratory-services-inc/d29898e4-535f-4fe8-ac85-adca3db6bb01)

## Related Officers

- [Kerun Hardeo](https://www.globalkeysolutions.net/people/kerun-hardeo/d6c75a34-ab9b-4541-883d-102c6ec8c131)
- [Yiying E. Chen](https://www.globalkeysolutions.net/people/yiying-e-chen/1fcf176f-3d89-45e3-8859-64f614cf14b3)

Company: https://www.globalkeysolutions.net/companies/icon-laboratory-services-inc/c186271a-4150-430b-90f5-2c41b012e330

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961