# FDA 483 - Western New York Energy, LLC - November 08, 2022

Source: https://www.keypedia.com/records/483/western-new-york-energy-llc/d06e268d-84dc-43b1-8b06-a1fab0d67e8b

> FDA 483 for Western New York Energy, LLC on November 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Western New York Energy, LLC
- Inspection Date: 2022-11-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Western New York Energy, LLC. in Medina, New York, an API manufacturer of 200 Proof Ethanol, revealed significant deficiencies in good manufacturing practices. The firm failed to ensure proper testing and release of its ethanol, lacked an effective quality unit, and exhibited inadequate control over facilities, equipment, and personnel training. These issues indicate a systemic failure to meet regulatory standards for drug substance manufacturing.

## Related Officers

- [William Leonard](https://www.keypedia.com/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)

Company: https://www.keypedia.com/companies/western-new-york-energy-llc/69cdec18-3233-4f75-9e6e-0dbba9a9d354

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