# FDA 483 - G. C. Hanford Manufacturing Co - March 20, 2025

Source: https://www.globalkeysolutions.net/records/483/g-c-hanford-manufacturing-co/7d3e53b0-04f9-4a3f-a3fc-2fab46926a9d

> FDA 483 for G. C. Hanford Manufacturing Co on March 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: G. C. Hanford Manufacturing Co
- Inspection Date: 2025-03-20
- Product Type: drugs
- Office Name: New York District Office
- Summary: G. C. Hanford Manufacturing Co. in Syracuse, NY, a drug product manufacturer, was inspected and cited for multiple significant deficiencies. The inspection revealed failures in quality control procedures for sterile media fills, poor facility maintenance including unsanitary conditions and damaged aseptic processing areas, and inadequately maintained equipment. Additionally, the firm lacked proper requalification of temperature-controlling units and had deficient environmental and personnel monitoring procedures in aseptic areas.

## Related Documents

- [483 - 2022-06-17](https://www.globalkeysolutions.net/records/483/g-c-hanford-manufacturing-co/f76c2866-722b-46c3-86ec-f7b124dac337)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/erik-w-koester/2bbab081-6783-40a1-83c1-b219bde22bd1)
- [Christian F. Gomez Lugo](https://www.globalkeysolutions.net/people/christian-f-gomez-lugo/866e531a-6354-45b2-8e43-1dfc9d146caf)
- [investigator](https://www.globalkeysolutions.net/people/ifechimere-i-okafor/c48399bf-47d9-4562-9130-1e6731eca07d)

Company: https://www.globalkeysolutions.net/companies/g-c-hanford-manufacturing-co/77953b74-ddef-41fd-95e2-2b15c12becad

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d