# FDA 483 - Aeropres Corporation - June 22, 2023

Source: https://www.globalkeysolutions.net/records/483/aeropres-corporation/dea7910e-a2ef-49a8-850d-d0319c794328

> FDA 483 for Aeropres Corporation on June 22, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aeropres Corporation
- Inspection Date: 2023-06-22
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Aeropres Corporation, a manufacturer of aerosol propellants for drug products in Morris, IL, revealed significant deficiencies in their quality control and data integrity practices. Observations included a failure of the quality unit to document and investigate non-conforming results, a lack of quality review for laboratory data, and inadequate controls to ensure the authenticity and integrity of computerized systems and raw data. These issues indicate a lack of adherence to Current Good Manufacturing Practice.

## 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/aeropres-corporation/94bce703-b82f-497c-a28f-9143596de025

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