# FDA 483 - Nanophase Technologies Corporation - April 13, 2023

Source: https://www.globalkeysolutions.net/records/483/nanophase-technologies-corporation/8272f957-6c93-4953-a84a-545653f7e600

> FDA 483 for Nanophase Technologies Corporation on April 13, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nanophase Technologies Corporation
- Inspection Date: 2023-04-13
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: Nanophase Technologies Corporation in Romeoville, IL, was inspected by the FDA, revealing significant data integrity and quality control issues. The firm failed to implement unique user access controls for analytical equipment and did not adequately verify raw material supplier Certificates of Analysis. These observations indicate a moderate level of non-compliance with good manufacturing practices.

## Related Officers

- [Peng Zhou](https://www.globalkeysolutions.net/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)

Company: https://www.globalkeysolutions.net/companies/nanophase-technologies-corporation/2b2b4bbe-7d35-4ece-8a79-dbffc6f82a51

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766