# FDA 483 - Precision Dose Inc. - September 11, 2025

Source: https://www.keypedia.com/records/483/precision-dose-inc/4273071e-3fed-4a19-9548-70b2221c37ca

> FDA 483 for Precision Dose Inc. on September 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Precision Dose Inc.
- Inspection Date: 2025-09-11
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: Precision Dose Inc., a repackager in South Beloit, IL, was cited for significant deficiencies in its quality control unit, specifically regarding the inconsistent handling of customer complaint investigation extensions, which was a repeat observation. Additionally, the firm failed to properly identify drug products, batch numbers, and processing phases on major equipment and production lines during repackaging activities. These issues indicate a lack of adequate control over critical quality and manufacturing processes.

## Related Documents

- [483 - 2019-01-28](https://www.keypedia.com/records/483/precision-dose-inc/3f27c402-71e1-418f-ba7f-93ddc847e5e9)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/ngozi-g-offor/d9d0aa28-6bd1-4427-a712-8716c96b1f3d)

Company: https://www.keypedia.com/companies/precision-dose-inc/c2c0cc83-172d-469c-9cda-6684ee762a91

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