# FDA 483 - Nova-Tech Inc. - March 15, 2022

Source: https://www.keypedia.com/records/483/nova-tech-inc/f750f29d-8fda-4632-b79d-393ff7e46cb3

> FDA 483 for Nova-Tech Inc. on March 15, 2022. Product: veterinary. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nova-Tech Inc.
- Inspection Date: 2022-03-15
- Product Type: veterinary
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: NovaTech Incorporated, a sterile animal drug manufacturer in Grand Island, NE, received a Form 483 citing significant deficiencies in its quality system. Observations included inadequate investigations into discrepancies, deficient complaint handling, and widespread failures in aseptic processing controls, environmental monitoring, and equipment maintenance. These issues collectively indicate a high risk of product contamination and compromise of sterility.

## Related Documents

- [483 - 2023-05-12](https://www.keypedia.com/records/483/nova-tech-inc/4552675c-5ed2-454a-abe8-0276e011dbc8)

## Related Officers

- [Susanna E. Ford](https://www.keypedia.com/people/susanna-e-ford/4332d436-f50b-4657-9d85-93c10bfe0cc8)
- [Consumer Safety Officer/ Federal Investigator](https://www.keypedia.com/people/lisa-l-flores/465a6807-55d7-4c3f-a415-c21ac4517bc9)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/nova-tech-inc/fe5c85d8-9a42-4481-bdf4-1df3773fe907

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8