# FDA 483 - NOVA LABORATORIES LIMITED - August 23, 2024

Source: https://www.keypedia.com/records/483/nova-laboratories-limited/b780cc12-bd8d-4179-8e39-018af33718ff

> FDA 483 for NOVA LABORATORIES LIMITED on August 23, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NOVA LABORATORIES LIMITED
- Inspection Date: 2024-08-23
- Product Type: biologics
- Office Name: Division of Blood Components and Devices
- Summary: An FDA inspection of Nova Laboratories Ltd in Wigston, Leicestershire, revealed significant deficiencies in their manufacturing operations. The firm failed to maintain equipment and utensils at appropriate intervals to prevent contamination of sterile drug products. Additionally, the company did not adequately qualify the airflow effectiveness in critical manufacturing areas, raising concerns about environmental control and product quality.

## Related Documents

- [EIR - 2019-03-12](https://www.keypedia.com/records/eir/nova-laboratories-limited/d57aadfb-54d3-4809-a5f5-dd0c207bc51f)
- [483 - 2024-08-23](https://www.keypedia.com/records/483/nova-laboratories-limited/e967beca-887b-4e23-ad75-b6d3159d1203)

## Related Officers

- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)
- [Feng Zhou](https://www.keypedia.com/people/feng-zhou/5cb267f1-2c3a-487c-b46d-ac1734d08bf9)

Company: https://www.keypedia.com/companies/nova-laboratories-limited/e161134f-af86-4c91-9418-661b453e43f8

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917