# FDA 483 - PPD Development, L.P. - May 14, 2026

Source: https://www.keypedia.com/records/483/ppd-development-lp/378f5be0-1030-40fb-b0fd-ea96e1302769

> FDA 483 for PPD Development, L.P. on May 14, 2026. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: PPD Development, L.P.
- Inspection Date: 2026-05-14
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of PPD Laboratories, GMP Lab in Middleton, WI, a biopharmaceuticals analytical facility, revealed a significant quality control issue. The firm used an expired reference standard in multiple studies without providing any justification for its continued use. This indicates a potential lapse in quality control and adherence to good manufacturing practices.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/ppd-development-lp/61346431-fa4f-4c39-9544-0c075a540d6b)
- [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

- [issuing_officer](https://www.keypedia.com/people/mohsen-rajabiabhari/cb1b2138-7b4f-4e5a-b87f-9b319b14ee81)
- [Jonathan R. Campos](https://www.keypedia.com/people/jonathan-r-campos/f4c6aba7-d0fe-43d2-95ae-5eb86a6659a4)

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
