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

Source: https://www.keypedia.com/records/483/nova-laboratories-limited/e967beca-887b-4e23-ad75-b6d3159d1203

> 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: International Compliance Team
- Summary: An FDA inspection of Nova Laboratories Ltd in Wigston, United Kingdom, revealed two significant observations concerning manufacturing controls. The firm was cited for inadequate maintenance of equipment and utensils to prevent contamination of drug products. Additionally, the inspection found that the firm had not properly qualified airflow effectiveness in critical manufacturing areas, raising concerns about the sterility and quality of its products.

## Related Officers

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

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321