# FDA 483 - Princeton Community Hospital Association - July 27, 2022

Source: https://www.globalkeysolutions.net/records/483/princeton-community-hospital-association/ffc75bd7-6390-4400-868d-b40ae0a905c4

> FDA 483 for Princeton Community Hospital Association on July 27, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Princeton Community Hospital Association
- Inspection Date: 2022-07-27
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: Princeton Community Hospital Association's blood bank was inspected from July 25-27, 2022, revealing a significant issue with the establishment and adherence to written standard operating procedures. Specifically, new equipment was validated and put into use without prior approval from the Laboratory Medical Director, and no formal SOP existed for equipment validation. This indicates a lapse in quality assurance and procedural control.

## Related Officers

- [Charles D. Boison](https://www.globalkeysolutions.net/people/charles-d-boison/b128f4a3-c1b1-409f-9291-27deb111d1e5)

Company: https://www.globalkeysolutions.net/companies/princeton-community-hospital-association/ca83b3af-f78f-4325-9dcb-5d7a72eefb2d

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64