# FDA 483 - PPD Development, L.P. - September 25, 2025

Source: https://www.keypedia.com/records/483/ppd-development-lp/e2239a11-ea51-47a5-b646-89e4ea475acb

> FDA 483 for PPD Development, L.P. on September 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PPD Development, L.P.
- Inspection Date: 2025-09-25
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: PPD Development, L.P. in Middleton, WI, a contract laboratory, was issued a Form 483 with three observations. The inspection revealed deficiencies in employee training for drug product processing, inadequate controls over temperature-controlled equipment, and a lack of written procedures for quality control unit responsibilities. These issues highlight concerns regarding good manufacturing practices and potential risks to product quality.

## Related Documents

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

## Related Officers

- [Beatrix D. Hippe](https://www.keypedia.com/people/beatrix-d-hippe/4a5a5258-3099-46cd-9e56-2dce60668ac5)
- [JeanClaude Garay](https://www.keypedia.com/people/jeanclaude-garay/62e387aa-73d3-4f69-8cc2-5607b7963d7f)
- [Consumer Safety Officer](https://www.keypedia.com/people/eric-d-bowles/bb6c783b-0933-4231-b79e-c591cbc50104)

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