# FDA 483 - PPD Development Ireland Ltd. - December 19, 2025

Source: https://www.keypedia.com/records/483/ppd-development-ireland-ltd/0b0663bb-38e7-4ceb-b2aa-291ecd992730

> FDA 483 for PPD Development Ireland Ltd. on December 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PPD Development Ireland Ltd.
- Inspection Date: 2025-12-19
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of PPD Development Ireland Ltd. in Athlone, Ireland, a contract laboratory testing facility, revealed significant deficiencies in their quality control unit's adherence to procedures. The firm consistently failed to complete stability testing within required windows for drug substances and products, despite numerous deviations and corrective actions over several years. Additionally, the company applied a complexity classification to quality control testing methods without providing adequate comprehensive hands-on training, contributing to a high rate of operator-related errors.

## Related Officers

- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.keypedia.com/companies/ppd-development-ireland-ltd/8ab4f405-986b-445c-a03a-56d7aeaa3913

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917