# FDA 483 - G. C. Hanford Manufacturing Co - June 17, 2022

Source: https://www.globalkeysolutions.net/records/483/g-c-hanford-manufacturing-co/f76c2866-722b-46c3-86ec-f7b124dac337

> FDA 483 for G. C. Hanford Manufacturing Co on June 17, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: G. C. Hanford Manufacturing Co
- Inspection Date: 2022-06-17
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of G. C. Hanford Manufacturing Co in Syracuse, NY, a contract manufacturing operation, revealed significant deficiencies in quality control unit procedures, equipment design for aseptic processing, and process validation. The firm failed to complete customer complaint and variance investigations within established timeframes, did not assure unidirectional airflow in aseptic areas after an Air Handling Unit replacement, and lacked proper process validation after a major tablet press upgrade, resulting in product yield issues.

## Related Documents

- [483 - 2025-03-20](https://www.globalkeysolutions.net/records/483/g-c-hanford-manufacturing-co/7d3e53b0-04f9-4a3f-a3fc-2fab46926a9d)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/juliana-m-badalucco/3fee9b67-1209-4f7e-8108-bd835251f6c9)
- [Drug Investigator](https://www.globalkeysolutions.net/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)
- [Consumer Safety Officer Drug Specialist](https://www.globalkeysolutions.net/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961