# FDA 483 - PPD, Inc., part of Thermo Fisher Scientific - August 15, 2019

Source: https://www.keypedia.com/records/483/ppd-inc-part-of-thermo-fisher-scientific/fcdabdca-78ed-452c-989f-ada0c19c3158

> FDA 483 for PPD, Inc., part of Thermo Fisher Scientific on August 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PPD, Inc., part of Thermo Fisher Scientific
- Inspection Date: 2019-08-15
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: PPD, Inc. in Wilmington, NC was inspected by the FDA from August 12-15, 2019. The inspection revealed a significant failure to ensure investigations were conducted in accordance with the general investigational plan and protocols specified in the IND. This included not following internal data validation procedures, unlocking subject records without prior sponsor approval, and issues with managing subject dose adjustments, leading to protocol violations.

## Related Officers

- [investigator](https://www.keypedia.com/people/eileen-j-bannerman/813432a8-60ce-427f-a0f6-fe6874bc4b59)
- [investigator](https://www.keypedia.com/people/cheryl-a-grandinetti/db17fca7-6b39-48b9-a7f3-86817b56a9a1)
- [Kassa Ayalew](https://www.keypedia.com/people/kassa-ayalew/e16b339e-6db4-4c0e-91ae-b70d586d9d97)

Company: https://www.keypedia.com/companies/ppd-inc-part-of-thermo-fisher-scientific/6e887c67-c334-42e7-80d9-cfa8be392b57

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7