# FDA 483 - Noble Life Sciences, Inc - July 08, 2022

Source: https://www.keypedia.com/records/483/noble-life-sciences-inc/4e7225fb-ce47-4293-a871-b0f43e46670e

> FDA 483 for Noble Life Sciences, Inc on July 08, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Noble Life Sciences, Inc
- Inspection Date: 2022-07-08
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Noble Life Sciences, Inc. in Sykesville, MD, a nonclinical laboratory, from June 27 to July 8, 2022, revealed significant deficiencies. Observations included failures in the quality assurance unit to manage deviations and ensure facility security, the use of uncalibrated equipment for environmental monitoring, and the omission of critical data integrity issues, such as the use of an out-of-tolerance pipette for animal dosing, from final study reports.

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## Related Officers

- [Hugh M. Mcclure](https://www.keypedia.com/people/hugh-m-mcclure/e69b7562-8fb5-4b7d-a506-a9bc0f0e9e43)

Company: https://www.keypedia.com/companies/noble-life-sciences-inc/221827eb-80e0-4ee8-aad7-35d3ac26391a

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