# FDA 483 - Unither Manufacturing LLC. - May 22, 2019

Source: https://www.keypedia.com/records/483/unither-manufacturing-llc/2c0d7158-40a8-4436-a5ba-0d7baa943cf7

> FDA 483 for Unither Manufacturing LLC. on May 22, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unither Manufacturing LLC.
- Inspection Date: 2019-05-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Unither Manufacturing LLC in Rochester, NY, was cited for significant quality control and equipment maintenance issues during an FDA inspection. Observations included the invalidation of out-of-specification investigations without scientific justification and deficiencies in batch production records regarding equipment identification. Additionally, the firm failed to properly maintain and sanitize equipment and utensils, leading to potential contamination risks for drug products.

## Related Documents

- [EIR - 2021-10-15](https://www.keypedia.com/records/eir/unither-manufacturing-llc/35b5e4b7-c6ab-489a-8767-c6b687e9fd68)
- [483 - 2021-10-15](https://www.keypedia.com/records/483/unither-manufacturing-llc/6de38ac5-0b73-4cd8-ac90-424201f85a4c)

## Related Officers

- [Johnna L. Bleem](https://www.keypedia.com/people/johnna-l-bleem/3fe669bf-e354-4cdc-9337-d5ceb23f1c9f)
- [Consumer Safety Officer/ORA/OMPTO/TOS](https://www.keypedia.com/people/niketa-patel/73efe456-da61-4345-8dec-7147b12b88d1)

Company: https://www.keypedia.com/companies/unither-manufacturing-llc/1af71ec2-4e77-473b-b1ba-28318c362e05

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248