# FDA 483 - Athea Laboratories Inc - January 25, 2017

Source: https://www.keypedia.com/records/483/athea-laboratories-inc/33a85d2b-32b7-413c-bd79-d4d93f56b176

> FDA 483 for Athea Laboratories Inc on January 25, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Athea Laboratories Inc
- Inspection Date: 2017-01-25
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Athea Laboratories Inc. in Milwaukee, WI, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in quality control procedures, specifically the failure to reject drug products that did not meet microbial specifications, and inadequate quarantine storage areas for incoming materials prior to release. These issues indicate a lack of proper controls to ensure product quality and prevent mix-ups.

## Related Documents

- [483 - 2023-12-20](https://www.keypedia.com/records/483/athea-laboratories-inc/85c42f63-095d-4cdd-9263-3c977cf8c86d)

## Related Officers

- [Ross J. Grigsby](https://www.keypedia.com/people/ross-j-grigsby/713f8252-3e41-4e6f-abea-8ca5bd48aa83)

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

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d