# FDA 483 - Aeropres Corp - June 27, 2023

Source: https://www.globalkeysolutions.net/records/483/aeropres-corp/8c545c62-7c6d-4815-a5ea-06a238370137

> FDA 483 for Aeropres Corp on June 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aeropres Corp
- Inspection Date: 2023-06-27
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Aeropres Corp in Manhattan, IL, was inspected by the FDA, revealing significant deficiencies in its quality unit, laboratory data review, and computerized system controls. The inspection found that the firm failed to investigate non-conforming results, lacked proper review of GC calibration data, and did not ensure the authenticity and integrity of electronic data, potentially impacting the quality of aerosol propellants. These issues indicate a lack of adherence to Current Good Manufacturing Practices.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/rafeeq-a-habeeb/ac58c0b7-bd42-4037-8ccb-bf0351b7744f)
- [Enrico Mangahis](https://www.globalkeysolutions.net/people/enrico-mangahis/372a40e1-2525-435b-a295-27cb5d75a763)

Company: https://www.globalkeysolutions.net/companies/aeropres-corp/b2100bd2-8177-4ee2-a77d-53679c4578d8

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