# FDA 483 - Zennova LLC - January 27, 2022

Source: https://www.keypedia.com/records/483/zennova-llc/cf587b9a-e326-4582-b437-a6e1df3877d1

> FDA 483 for Zennova LLC on January 27, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zennova LLC
- Inspection Date: 2022-01-27
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Zennova LLC, a control testing laboratory in Orangeburg, NY, was inspected by the FDA from January 21-27, 2022, and received a Form 483 with three observations. The inspection revealed significant deficiencies in computer system controls, instrument calibration, and quality control unit procedures, indicating a lack of adherence to good manufacturing practices.

## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

Company: https://www.keypedia.com/companies/zennova-llc/8bf3cbed-d0f1-4c07-9742-173db3ed5b4e

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