# FDA 483 - Athea Laboratories Inc - December 20, 2023

Source: https://www.globalkeysolutions.net/records/483/athea-laboratories-inc/85c42f63-095d-4cdd-9263-3c977cf8c86d

> FDA 483 for Athea Laboratories Inc on December 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Athea Laboratories Inc
- Inspection Date: 2023-12-20
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Athea Laboratories Inc. in Milwaukee, WI, received a Form 483 with two observations related to manufacturing and quality control deficiencies. The inspection revealed issues with maintaining separate production areas due to a temporary dining area in the GMP zone and a lack of formal change control. Additionally, the firm failed to perform identity testing on incoming active pharmaceutical ingredients, relying solely on supplier Certificates of Analysis.

## Related Documents

- [483 - 2017-01-25](https://www.globalkeysolutions.net/records/483/athea-laboratories-inc/33a85d2b-32b7-413c-bd79-d4d93f56b176)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/athea-laboratories-inc/7bb39549-7654-4ea5-a643-fb68eeb26a74

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