# FDA 483 - PPD Development, L.P. - Unknown Date

Source: https://www.keypedia.com/records/483/ppd-development-lp/61346431-fa4f-4c39-9544-0c075a540d6b

> FDA 483 for PPD Development, L.P. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PPD Development, L.P.
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of PPD Development LLC in Middleton, WI, a Contract Research Organization (CRO), identified a data integrity issue related to the reporting of analytical results. The firm reported results for next generation impactor (NGI) data that were below the established limits of quantification (LOQs), indicating potential inaccuracies in their analytical methods or reporting practices. This observation suggests a moderate severity issue concerning data reliability in their in-vitro bioequivalence studies.

## Related Documents

- [483 - 2026-05-14](https://www.keypedia.com/records/483/ppd-development-lp/378f5be0-1030-40fb-b0fd-ea96e1302769)
- [EIR - 2021-07-16](https://www.keypedia.com/records/eir/ppd-development-lp/f8eac3b9-7684-413c-8dba-fe6d849d482a)
- [483 - 2021-07-12](https://www.keypedia.com/records/483/ppd-development-lp/ccfcb620-b78a-4d74-bd5f-0ac42cce65eb)
- [483 - 2023-04-05](https://www.keypedia.com/records/483/ppd-development-lp/199ff82e-a934-4fac-9fec-faa0405a7238)
- [483 - 2025-09-25](https://www.keypedia.com/records/483/ppd-development-lp/e2239a11-ea51-47a5-b646-89e4ea475acb)

## Related Officers

- [Bioresearch Monitoring Specialis](https://www.keypedia.com/people/denise-l-burosh/075a442f-67e0-4a65-9c09-e8819a329773)
- [other](https://www.keypedia.com/people/makini-cobourne-duval/8eec148c-3eb2-4673-87ea-efc4e64821bb)
- [issuing_officer](https://www.keypedia.com/people/himanshu-gupta/e7b67273-e37d-47b6-b6bb-ca3758116f5d)

Company: https://www.keypedia.com/companies/ppd-development-lp/0d495b78-4879-42fc-8887-4e0294e69720

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d