# FDA 483 - Avlon Industries, Inc - January 24, 2023

Source: https://www.globalkeysolutions.net/records/483/avlon-industries-inc/7ddc7d72-ab43-4c0b-a867-f9045e12790e

> FDA 483 for Avlon Industries, Inc on January 24, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avlon Industries, Inc
- Inspection Date: 2023-01-24
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Avlon Industries, Inc., a drug product manufacturer in Melrose Park, IL, was cited for numerous significant deficiencies in its quality control unit, laboratory controls, and manufacturing processes. The inspection revealed a systemic lack of written procedures, validation, and testing, impacting product quality, identity, strength, and purity. These issues suggest a broad failure to adhere to good manufacturing practices.

## Related Documents

- [483 - 2024-07-15](https://www.globalkeysolutions.net/records/483/avlon-industries-inc/89b326e5-6711-45e8-9163-400739a004c7)

## Related Officers

- [Enrico Mangahis](https://www.globalkeysolutions.net/people/enrico-mangahis/372a40e1-2525-435b-a295-27cb5d75a763)
- [Investigator](https://www.globalkeysolutions.net/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.globalkeysolutions.net/companies/avlon-industries-inc/4c736e7a-8f14-42d8-9d02-2cb1ecd6d97d

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