# FDA 483 - University Of Pittsburgh Medical Center (Centralized Packaging (CPAK)) - August 14, 2025

Source: https://www.globalkeysolutions.net/records/483/university-of-pittsburgh-medical-center-centralized-packaging-cpak/9777c558-79aa-446c-8287-9afdebddc4cd

> FDA 483 for University Of Pittsburgh Medical Center (Centralized Packaging (CPAK)) on August 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University Of Pittsburgh Medical Center (Centralized Packaging (CPAK))
- Inspection Date: 2025-08-14
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of University of Pittsburgh Medical Center Centralized Packaging in Pittsburgh, PA, identified significant deficiencies in their drug repackaging operations. The firm failed to conduct cleaning validation studies to prevent penicillin cross-contamination, did not thoroughly investigate 750 identified defects, and assigned expiration dates to repackaged drug products without supporting stability data. These issues indicate a lack of adherence to good manufacturing practices.

## Related Officers

- [Yaharn Su](https://www.globalkeysolutions.net/people/yaharn-su/75b7f7fd-d853-436e-b538-386a8c6df3cb)

Company: https://www.globalkeysolutions.net/companies/university-of-pittsburgh-medical-center-centralized-packaging-cpak/fc764ab6-f48f-4c41-83c2-26db7c1f8385

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8