# FDA 483 - Keystone Bioanalytical, Inc. - June 28, 2019

Source: https://www.keypedia.com/records/483/keystone-bioanalytical-inc/d5e38f0c-41df-4575-8624-37b5578f8450

> FDA 483 for Keystone Bioanalytical, Inc. on June 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Keystone Bioanalytical, Inc.
- Inspection Date: 2019-06-28
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Keystone Bioanalytical, Inc. in North Wales, PA, conducted from June 24-28, 2019, identified a significant issue regarding data integrity and quality control. The contract research organization failed to report all method validation data, specifically omitting results from LLOQ samples that, when included, demonstrated out-of-specification inter-batch precision. This indicates a failure to ensure the accuracy and reliability of their bioanalytical method validation processes.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kara-a-scheibner/63643a3f-4a8e-4dcc-8f1a-6fcf98519aad)
- [Joseph L. Despins](https://www.keypedia.com/people/joseph-l-despins/c84402a8-7ebb-45ab-b1b9-c43a143c5fb8)

Company: https://www.keypedia.com/companies/keystone-bioanalytical-inc/2a9f138d-b3f1-410a-b7b3-8c46c6b04247

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