# FDA 483 - Diversified CPC International - June 16, 2023

Source: https://www.globalkeysolutions.net/records/483/diversified-cpc-international/6394f1fd-f879-4a0d-bfb7-0e07298a9a8f

> FDA 483 for Diversified CPC International on June 16, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Diversified CPC International
- Inspection Date: 2023-06-16
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Diversified CPC International in Channahon, IL, revealed significant deficiencies in the control of manufacturing, testing, and release of aerosol propellants used in drug products. Key issues included a lack of quality unit oversight, inadequate assessment of propellant contamination, and widespread problems with data integrity and computerized system controls. The firm also failed to establish proper method validation and system suitability for analytical testing, indicating a serious lack of adherence to current Good Manufacturing Practices.

## Related Officers

- [Enrico Mangahis](https://www.globalkeysolutions.net/people/enrico-mangahis/372a40e1-2525-435b-a295-27cb5d75a763)
- [Investigator ](https://www.globalkeysolutions.net/people/logan-t-williams/a1febf59-970a-4e4e-9c0c-f4ad385582d7)
- [Paranthaman Senthamarai Kannan](https://www.globalkeysolutions.net/people/paranthaman-senthamarai-kannan/12221263-b29b-4696-9e6e-84e659ae43cd)

Company: https://www.globalkeysolutions.net/companies/diversified-cpc-international/5309c991-ab42-4213-ac07-033a5e886742

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669