# FDA 483 - Unither Manufacturing LLC. - October 15, 2021

Source: https://www.globalkeysolutions.net/records/483/unither-manufacturing-llc/6de38ac5-0b73-4cd8-ac90-424201f85a4c

> FDA 483 for Unither Manufacturing LLC. on October 15, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unither Manufacturing LLC.
- Inspection Date: 2021-10-15
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Unither Manufacturing LLC. in Rochester, NY, a contract human drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight a failure to thoroughly investigate discrepancies, inadequate maintenance and sanitization of equipment, and a lack of adherence to quality control procedures. Repeated issues with environmental control and a lack of proper documentation for component approval and cleaning records indicate systemic problems affecting the quality and safety of sterile human drug products.

## Related Documents

- [483 - 2019-05-22](https://www.globalkeysolutions.net/records/483/unither-manufacturing-llc/2c0d7158-40a8-4436-a5ba-0d7baa943cf7)
- [EIR - 2021-10-15](https://www.globalkeysolutions.net/records/eir/unither-manufacturing-llc/35b5e4b7-c6ab-489a-8767-c6b687e9fd68)

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)
- [William Leonard](https://www.globalkeysolutions.net/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961